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Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02229227
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : June 29, 2018
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Albiglutide
Drug: Insulin Glargine and Insulin Lispro
Enrollment 814
Recruitment Details This study was conducted from 21-Nov-2014 to 24-Jul-2017 at 186 centers in 14 countries: Canada, United States of America, Mexico, Brazil, Hungary, Poland, France, Germany, Italy, Spain, United Kingdom, Korea, Philippines and South Africa.
Pre-assignment Details A total of 2004 participants were screened, of which 973 participants were screen failures and 160 participants were re-screened. A total of 1031 participants then entered the standardization period, of which 217 participants were standardization failures. A total of 814 participants were randomized in the study.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 milligrams (mg) weekly subcutaneous (SC) injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period. During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Period Title: Overall Study
Started 402 412
Completed 351 350
Not Completed 51 62
Reason Not Completed
Adverse Event             14             9
Lack of Efficacy             3             3
Protocol Violation             6             8
Protocol defined stopping criteria             1             3
Lost to Follow-up             3             3
Study terminated by sponsor             11             11
Withdrawal by Subject             8             12
Other             0             1
Physician Decision             5             12
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine Total
Hide Arm/Group Description During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period. During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period. Total of all reporting groups
Overall Number of Baseline Participants 402 412 814
Hide Baseline Analysis Population Description
Full Analysis (FA) Population comprised of all participants who were randomly assigned to treatment (who did not receive any study treatment were also included).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 402 participants 412 participants 814 participants
58.0  (9.40) 58.1  (9.49) 58.1  (9.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 402 participants 412 participants 814 participants
Female
228
  56.7%
214
  51.9%
442
  54.3%
Male
174
  43.3%
198
  48.1%
372
  45.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 402 participants 412 participants 814 participants
American Indian or Alaska Native
43
  10.7%
28
   6.8%
71
   8.7%
Asian-Central/South Asian (A) Heritage (H)
5
   1.2%
8
   1.9%
13
   1.6%
Asian-Japanese H/East AH/South East AH
25
   6.2%
24
   5.8%
49
   6.0%
Black or African American
37
   9.2%
32
   7.8%
69
   8.5%
Native Hawaiian or Other Pacific Islander
1
   0.2%
3
   0.7%
4
   0.5%
White
284
  70.6%
312
  75.7%
596
  73.2%
Multiple-Black or African American and White
7
   1.7%
5
   1.2%
12
   1.5%
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Hide Description HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day -1) and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 345 350
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of glycosylated hemoglobin
-1.04  (0.041) -1.10  (0.040)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.
Statistical Test of Hypothesis P-Value <0.0001
Comments Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.05 to 0.17
Estimation Comments Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.
2.Secondary Outcome
Title Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26
Hide Description Participants who did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 were those participants treated with once-weekly albiglutide that were able to replace prandial insulin without lispro re-introduction through Week 26. Number of participants treated with once-weekly albiglutide that were able to discontinue insulin lispro at Week 4 and did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 have been presented.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
Overall Number of Participants Analyzed 402
Measure Type: Number
Unit of Measure: Participants
218
3.Secondary Outcome
Title Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26
Hide Description Severe hypoglycemia was considered as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 milligrams per deciliters (mg/dL) (<=3.9 millimoles per liters [mmol/L]).
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Percentage of participants
57.2 75.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.31 to 0.60
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
4.Secondary Outcome
Title Change From Baseline in Body Weight at Week 26
Hide Description Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Time Frame Baseline (Day -1) and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 349 352
Least Squares Mean (Standard Error)
Unit of Measure: Kilograms
-1.95  (0.207) 2.43  (0.205)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.37
Confidence Interval (2-Sided) 95%
-4.93 to -3.82
Estimation Comments Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
5.Secondary Outcome
Title Change From Baseline to Week 26 in Body Weight
Hide Description Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Change from Baseline to Week 26 in body weight are presented. FA Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame Baseline (Day -1) to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Least Squares Mean (Standard Error)
Unit of Measure: Kilograms
Week 4, n=368,384 Number Analyzed 368 participants 384 participants
-0.55  (0.091) 0.66  (0.091)
Week 5, n=382,393 Number Analyzed 382 participants 393 participants
-0.95  (0.102) 0.85  (0.102)
Week 10, n=379,397 Number Analyzed 379 participants 397 participants
-1.71  (0.133) 1.46  (0.131)
Week 18, n=365,372 Number Analyzed 365 participants 372 participants
-1.96  (0.177) 2.06  (0.175)
Week 26, n=349,352 Number Analyzed 349 participants 352 participants
-1.95  (0.207) 2.43  (0.205)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 4
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-1.43 to -1.00
Estimation Comments Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 4 has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 5
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-2.05 to -1.55
Estimation Comments Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 5 has been presented.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 10
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.17
Confidence Interval (2-Sided) 95%
-3.51 to -2.82
Estimation Comments Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 10 has been presented.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 18
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.01
Confidence Interval (2-Sided) 95%
-4.48 to -3.54
Estimation Comments Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 18 has been presented.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.37
Confidence Interval (2-Sided) 95%
-4.93 to -3.82
Estimation Comments Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 26 has been presented.
6.Secondary Outcome
Title Total Daily Insulin Dose at Week 26
Hide Description Insulin dose at Week 26 was defined as the prescribed insulin dose at Week 25. Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 26 is presented. Only those participants available at the specified time points were analyzed.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 342 341
Least Squares Mean (Standard Error)
Unit of Measure: International Units
70.36  (2.160) 131.19  (2.149)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -60.83
Confidence Interval (2-Sided) 95%
-66.57 to -55.10
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
7.Secondary Outcome
Title Change From Baseline to Week 26 in HbA1c
Hide Description HbA1c is glycosylated hemoglobin and was measured up to Week 26. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of glycosylated hemoglobin
Week 4, n=358,375 Number Analyzed 358 participants 375 participants
-0.59  (0.023) -0.47  (0.023)
Week 5, n=374,392 Number Analyzed 374 participants 392 participants
-0.67  (0.026) -0.58  (0.025)
Week 10, n=376,390 Number Analyzed 376 participants 390 participants
-0.88  (0.034) -0.96  (0.033)
Week 18, n=360,365 Number Analyzed 360 participants 365 participants
-1.04  (0.038) -1.14  (0.038)
Week 26, n=345,350 Number Analyzed 345 participants 350 participants
-1.04  (0.041) -1.1  (0.040)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 4
Type of Statistical Test Non-Inferiority
Comments Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.18 to -0.07
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 5
Type of Statistical Test Non-Inferiority
Comments Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.15 to -0.02
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 10
Type of Statistical Test Non-Inferiority
Comments Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.01 to 0.17
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 18
Type of Statistical Test Non-Inferiority
Comments Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
0.01 to 0.21
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 26
Type of Statistical Test Non-Inferiority
Comments Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.05 to 0.17
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.
8.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Hide Description FPG was measured at Baseline (Day -1). FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the fasting serum glucose (FSG) values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 345 349
Least Squares Mean (Standard Error)
Unit of Measure: Millimoles per Liter
-2.01  (0.120) -1.46  (0.121)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.86 to -0.25
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
9.Secondary Outcome
Title Change From Baseline to Week 26 in FPG
Hide Description FPG was measured at Baseline (Day -1) up to Week 26. FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the FSG values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Least Squares Mean (Standard Error)
Unit of Measure: Millimoles per Liter
Week 4, n=356,371 Number Analyzed 356 participants 371 participants
-1.30  (0.119) -0.76  (0.118)
Week 5, n=366,388 Number Analyzed 366 participants 388 participants
-1.07  (0.126) -0.88  (0.125)
Week 18, n=348,353 Number Analyzed 348 participants 353 participants
-1.76  (0.124) -1.23  (0.124)
Week 26, n=345,349 Number Analyzed 345 participants 349 participants
-2.01  (0.120) -1.46  (0.121)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 4
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.84 to -0.24
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 5
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.51 to 0.13
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 18
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-0.85 to -0.22
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.86 to -0.25
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.
10.Secondary Outcome
Title Number of Participants Achieving HbA1c <7.0% at Week 26
Hide Description HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% at Week 26 are presented.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Participants
244 255
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7026
Comments Non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.71 to 1.31
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
11.Secondary Outcome
Title Number of Participants Achieving HbA1c <7.0% up to Week 26
Hide Description HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% up to Week 26 are presented.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Participants
Week 4 142 139
Week 5 157 182
Week 10 220 261
Week 18 251 281
Week 26 244 255
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2883
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.84 to 1.64
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 5
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3034
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.59 to 1.15
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 10
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0151
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.52 to 0.98
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 18
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0518
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.54 to 1.03
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7026
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.71 to 1.31
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.
12.Secondary Outcome
Title Number of Participants Achieving a HbA1c <6.5% at Week 26
Hide Description Number of participants achieving a HbA1c <6.5% at Week 26 are presented.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Participants
147 169
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2298
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.63 to 1.17
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
13.Secondary Outcome
Title Number of Participants Achieving a HbA1c <6.5% up to Week 26
Hide Description Number of participants achieving a HbA1c <6.5% up to Week 26 are presented.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Participants
Week 4 39 33
Week 5 63 62
Week 10 116 140
Week 18 150 178
Week 26 147 169
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2143
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.78 to 2.23
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 5
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4703
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.80 to 1.91
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 10
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2139
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.58 to 1.14
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 18
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0790
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.59 to 1.11
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2298
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.63 to 1.17
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.
14.Secondary Outcome
Title Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26
Hide Description Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants who met prespecified criteria for severe, persistent hyperglycemia at Week 26 are presented.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Participants
3 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8292
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.24 to 4.77
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
15.Secondary Outcome
Title Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26
Hide Description Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants meeting prespecified criteria for severe, persistent hyperglycemia up to Week 26 are presented.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Participants
0 to <=4 Weeks 0 0
>4 to <=5 Weeks 0 0
>5 to <=10 Weeks 2 0
>10 to <=18 Weeks 0 1
>18 to <=26 Weeks 1 2
16.Secondary Outcome
Title Total Daily Insulin Dose at Week 4, Week 10 and Week 18
Hide Description Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 4, Week 10 and Week 18 is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame Weeks 4, 10, and 18
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Least Squares Mean (Standard Error)
Unit of Measure: International Units
Week 4, n=388,403 Number Analyzed 388 participants 403 participants
50.53  (1.183) 106.91  (1.187)
Week 10, n=375,386 Number Analyzed 375 participants 386 participants
57.99  (1.597) 121.69  (1.589)
Week 18, n=359,361 Number Analyzed 359 participants 361 participants
68.23  (2.010) 130.22  (1.998)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 4
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -56.38
Confidence Interval (2-Sided) 95%
-59.19 to -53.57
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 10
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -63.70
Confidence Interval (2-Sided) 95%
-67.78 to -59.62
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 18
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -62.00
Confidence Interval (2-Sided) 95%
-67.29 to -56.70
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.
17.Secondary Outcome
Title Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits
Hide Description Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily basal insulin (insulin glargine) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame Weeks 4, 10, 18, and 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Least Squares Mean (Standard Error)
Unit of Measure: International Units
Week 4, n=388,403 Number Analyzed 388 participants 403 participants
49.97  (0.534) 50.94  (0.536)
Week 10, n=375,386 Number Analyzed 375 participants 386 participants
56.14  (0.767) 55.79  (0.761)
Week 18, n=359,361 Number Analyzed 359 participants 361 participants
59.42  (0.928) 59.18  (0.920)
Week 26, n=342,341 Number Analyzed 342 participants 341 participants
59.83  (0.996) 59.43  (0.988)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.97
Confidence Interval (2-Sided) 95%
-2.25 to 0.30
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 10
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-1.64 to 2.33
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 18
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-2.21 to 2.69
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7699
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-2.25 to 3.04
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.
18.Secondary Outcome
Title Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits
Hide Description Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily bolus insulin (insulin lispro) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame Weeks 4, 10, 18, and 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Least Squares Mean (Standard Error)
Unit of Measure: International Units
Week 4, n=388,403 Number Analyzed 388 participants 403 participants
0.62  (0.887) 56.67  (0.892)
Week 10, n=375,386 Number Analyzed 375 participants 386 participants
1.90  (1.147) 66.66  (1.144)
Week 18, n=359,361 Number Analyzed 359 participants 361 participants
8.89  (1.436) 71.81  (1.430)
Week 26, n=342,341 Number Analyzed 342 participants 341 participants
10.64  (1.523) 72.47  (1.517)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 4
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -56.05
Confidence Interval (2-Sided) 95%
-58.17 to -53.94
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 10
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -64.76
Confidence Interval (2-Sided) 95%
-67.68 to -61.85
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments Week 18
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -62.92
Confidence Interval (2-Sided) 95%
-66.69 to -59.15
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -61.83
Confidence Interval (2-Sided) 95%
-65.85 to -57.81
Estimation Comments Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.
19.Secondary Outcome
Title Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26
Hide Description Total number of weekly insulin injections (7 days) to achieve glycemic control at Baseline/Randomization and Week 4, 10, 18, and 26 are presented. Only those participants available at the specified time points were analyzed represented by n=X,X in category titles.
Time Frame Baseline (Day -1) and Weeks 4, 10, 18 and 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Mean (Standard Deviation)
Unit of Measure: Insulin Injections
Baseline, n=401,412 Number Analyzed 401 participants 412 participants
28.79  (1.470) 28.00  (0.000)
Week 4, n=388,403 Number Analyzed 388 participants 403 participants
8.11  (1.506) 28.00  (0.000)
Week 10, n=375,386 Number Analyzed 375 participants 386 participants
9.06  (3.121) 28.00  (0.000)
Week 18, n=359,361 Number Analyzed 359 participants 361 participants
12.62  (7.330) 28.00  (0.000)
Week 26, n=342,341 Number Analyzed 342 participants 341 participants
13.22  (7.758) 28.00  (0.000)
20.Secondary Outcome
Title Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26
Hide Description Percentage of participants achieving HbA1c <7.0% without weight gain are presented.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Percentage of participants
49.8 21.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.50
Confidence Interval (2-Sided) 95%
2.52 to 4.86
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
21.Secondary Outcome
Title Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26
Hide Description Percentage of participants achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia are presented.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Percentage of participants
21.1 9.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.36
Confidence Interval (2-Sided) 95%
1.54 to 3.60
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
22.Secondary Outcome
Title Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26
Hide Description Percentage of participants achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia are presented.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FA Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 402 412
Measure Type: Number
Unit of Measure: Percentage of participants
15.9 3.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albiglutide + Insulin Glargine, Insulin Lispro + Insulin Glargine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.78
Confidence Interval (2-Sided) 95%
2.21 to 6.48
Estimation Comments Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.
23.Secondary Outcome
Title Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication
Hide Description AE is any untoward medical occurrence in a participant, temporally associated with use of medicinal product (MP), whether or not considered related to MP. AE can be any unfavorable, unintended sign (also an abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Safety Population: All participants who received at least 1 dose of randomized study medication. A participant randomized to Albiglutide + Insulin glargine by mistake received Insulin Lispro + Insulin Glargine instead. Since this participant received actual treatment as Insulin Lispro + Insulin Glargine, was summarized as such in Safety Population.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
AE 261 254
SAE 23 31
AE leading to study medication discontinuation 12 6
24.Secondary Outcome
Title Number of Participants With Other AE of Special Interest
Hide Description AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a MP, whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. AE of special interest included hypoglycemic events, cardiovascular events, gastrointestinal events, injection site reactions, potential systemic allergic reactions, pancreatitis, pancreatic cancer, malignant neoplasms following treatment with insulin, diabetic retinopathy events, appendicitis, liver events, pneumonia, and atrial fibrillation/flutter.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
Hypoglycemic Events 305 361
Cardiovascular Events 7 9
Gastrointestinal Events 102 53
Injection Site Reactions 8 1
Systemic Allergic Reactions 3 0
Pancreatitis 1 0
Pancreatic cancer 0 0
Malignant Neoplasm 2 2
Diabetic Retinopathy 4 17
Appendicitis 1 0
Liver Events 0 2
Pneumonia 1 3
Atrial Fibrillation/Flutter 4 1
25.Secondary Outcome
Title Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26
Hide Description Hypoglycemic events with confirmed home plasma glucose monitoring <3.9 millimoles per Liter and/or requiring third party intervention were severe, documented symptomatic (DS) and asymptomatic hypoglycemic events. Participants with more than one hypoglycemic event are counted in all categories reported. Any severe, documented symptomatic, and asymptomatic hypoglycemic events in 3-month intervals (i.e., from Day 0 to Week 12, >Week 12 to Week 26) are presented.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Percentage of participants
Any event: Onset date falls under 0 to <= 12 weeks 55.3 79.2
Any event: Onset date falls > 12 to <= 26 Weeks 60.3 79.4
Severe: Onset date falls under 0 to <= 12 weeks 1.8 3.6
Severe: Onset date falls > 12 to <= 26 Weeks 0.8 1.9
DS: Onset date falls under 0 to <= 12 weeks 33.8 63.0
DS: Onset date falls > 12 to <= 26 Weeks 40.8 62.0
Asymptomatic: Onset date under 0 to <= 12 weeks 38.3 56.9
Asymptomatic: Onset date falls > 12 to <= 26 Weeks 44.3 54.7
26.Secondary Outcome
Title Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)
Hide Description The American Diabetes Association has categorized hypoglycemic events as follows: Severe, documented symptomatic, asymptomatic, probably symptomatic and pseudohypoglycemia. Number of participants with hypoglycemic events in total are also presented.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
Severe 9 22
Documented Symptomatic 203 299
Asymptomatic 230 293
Probably Symptomatic 29 52
Pseudohypoglycemia 45 83
Missing 9 13
Total 305 361
27.Secondary Outcome
Title Number of Participants With Daytime and Nocturnal Hypoglycemia
Hide Description Daytime hypoglycemia was defined as hypoglycemic events with an onset between 06:00 hours and 00:00 hours (inclusive), and nocturnal hypoglycemia (in total and by category), defined as hypoglycemic events with an onset between 00:01 hours and 05:59 hours (inclusive). Number of participants with daytime and nocturnal hypoglycemia (in total and by category) are presented.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
Any (Total) Daytime Hypoglycemic Event 288 356
Any (Total) Nocturnal Hypoglycemic Event 155 225
Severe Daytime Hypoglycemic Event 6 14
Severe Nocturnal Hypoglycemic Event 4 6
Documented Symptomatic Daytime Hypoglycemic event 187 293
Documented Symptomatic Nocturnal Hypoglycemia 101 152
Asymptomatic Daytime Hypoglycemic event 217 281
Asymptomatic Nocturnal Hypoglycemic event 77 106
Probably Symptomatic Daytime Hypoglycemic event 22 44
Probably Symptomatic Nocturnal Hypoglycemic event 7 21
Pseudohypoglycemia Daytime Hypoglycemic event 36 70
Pseudohypoglycemia Nocturnal Hypoglycemic event 17 34
Missing Daytime Hypoglycemic Event 9 11
Mising Nocturnal Hypoglycemic Event 2 4
28.Secondary Outcome
Title Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms
Hide Description Number of participants with hypoglycemia with blood glucose <56 mg/dL (<3.1 mmol/L), regardless of symptoms are presented.
Time Frame Up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
141 239
29.Secondary Outcome
Title Number of Participants With Hematology Values of Clinical Concern
Hide Description Hematology parameters included basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, neutrophils, neutrophil bands, platelets, red blood cell (RBC) count, segmented neutrophils and white blood cell (WBC) count. The potential clinical concern values were: Hematocrit >0.05 below lower limit of normal (LLN) and >0.04 above upper limit of normal (ULN), hemoglobin: >20 grams cells per Liter (g/L) below LLN and >10 g/L above ULN, lymphocytes: <0.5 x LLN, neutrophils: <1 giga cells per liter (GI/L), platelets: <80 GI/L and >500 GI/L, segmented neutrophils: <0.5 x LLN, RBC count: >1 GI/L below LLN and >5 GI/L above ULN and none for basophils, eosinophils, monocytes, neutrophil bands and RBC count. Only those parameters for which at least one value of potential clinical concern was reported are summarized.
Time Frame Up to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 394 407
Measure Type: Number
Unit of Measure: Participants
Hematocrit: >0.05 (fraction) below LLN 5 6
Hematocrit: >0.04 (fraction) above ULN 9 12
Hemoglobin: >20 g/L below LLN 9 9
Hemoglobin: >10 g/L above ULN 2 3
Leukocytes: >1 GI/L below LLN 1 1
Leukocytes: >5 GI/L above ULN 4 1
Neutrophils: <1 GI/L 2 3
Neutrophils, Segmented: <0.5 x LLN 2 3
Platelets: <80 GI/L 1 1
Platelets: >500 GI/L 3 1
30.Secondary Outcome
Title Number of Participants With Clinical Chemistry Values of Clinical Concern
Hide Description Clinical chemistry parameters and their potential clinical concern values were: albumin (>5 g/L above ULN or below LLN), alkaline phosphatase(>3 x ULN), alanine aminotransferase (>3 x ULN), aspartate aminotransferase (>3 x ULN), carbon dioxide content (<16 millimoles per Liter [mmol/L] and > 40 mmol/L), blood urea nitrogen (>2 x ULN), calcium (<1.8 mmol/L and >3.0 mmol/L), chloride (none), creatinine (>159 micromoles/Liter), direct bilirubin (>1.35 x ULN), gamma glutamyl transferase (>3 x ULN), glucose (fasting) (<3 mmol/L and >22 mmol/L), magnesium (<0.411 mmol/L and >1.644 mmol/L), phosphate (>0.323 mmol/L above ULN or below LLN), potassium (>0.5 mmol/L below LLN and >1.0 mmol/L above ULN), sodium (>5 mmol/L above ULN or below LLN), triglycerides (> 9.04 mmol/L), total bilirubin (>1.5 x ULN), total protein (>15 g/L above ULN or below LLN) and uric acid (>654 umol/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized.
Time Frame Up to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
Fasting Serum Glucose: <3 mmol/L, n= 394,405 Number Analyzed 394 participants 405 participants
12 16
Fasting Serum Glucose: >22 mmol/L, n= 394,405 Number Analyzed 394 participants 405 participants
0 1
Fasting Plasma Glucose: <3 mmol/L, n= 388,406 Number Analyzed 388 participants 406 participants
9 14
Fasting Plasma Glucose: >22 mmol/L, n= 388,406 Number Analyzed 388 participants 406 participants
1 0
Albumin: >5 g/L below LLN, n=394,407 Number Analyzed 394 participants 407 participants
0 0
Albumin: >5 g/L above ULN, n=394,407 Number Analyzed 394 participants 407 participants
0 0
Calcium: <1.8 mmol/L, n=394,407 Number Analyzed 394 participants 407 participants
1 1
Calcium: >3.0 mmol/L, n=394,407 Number Analyzed 394 participants 407 participants
0 0
Carbon Dioxide: <16 mmol/L, n=394,407 Number Analyzed 394 participants 407 participants
5 8
Carbon Dioxide: >40 mmol/L, n=394,407 Number Analyzed 394 participants 407 participants
0 0
Magnesium: <0.411 mmol/L, n=394,407 Number Analyzed 394 participants 407 participants
1 1
Magnesium: >1.644 mmol/L, n=394,407 Number Analyzed 394 participants 407 participants
0 0
Phosphate: >0.323 mmol/L below LLN, n=394,407 Number Analyzed 394 participants 407 participants
0 0
Phosphate: >0.323 mmol/L above ULN, n=394,407 Number Analyzed 394 participants 407 participants
2 4
Potassium: >0.5 mmol/L below LLN, n=394,407 Number Analyzed 394 participants 407 participants
1 0
Potassium: >1.0 mmol/L above ULN, n=394,407 Number Analyzed 394 participants 407 participants
0 1
Protein: >15 g/L below LLN, n=394,407 Number Analyzed 394 participants 407 participants
0 0
Protein: >15 g/L above ULN, n=394,407 Number Analyzed 394 participants 407 participants
0 0
Sodium: >5 mmol/L below LLN, n=394,407 Number Analyzed 394 participants 407 participants
1 0
Sodium: >5 mmol/L above ULN, n=394,407 Number Analyzed 394 participants 407 participants
1 0
Triglycerides: >9.04 mmol/L, n=393,405 Number Analyzed 393 participants 405 participants
7 1
Urate: >654 μmol/L, n=394,407 Number Analyzed 394 participants 407 participants
0 2
Urea: >2 x ULN, n=394,407 Number Analyzed 394 participants 407 participants
2 1
Alanine Aminotransferase: >3 x ULN, n=396,410 Number Analyzed 396 participants 410 participants
0 5
Alkaline Phosphatase: >3 x ULN, n=396,410 Number Analyzed 396 participants 410 participants
1 0
Aspartate Aminotransferase: >3 x ULN, n=396,410 Number Analyzed 396 participants 410 participants
0 2
Bilirubin: >1.5 x ULN, n=396,410 Number Analyzed 396 participants 410 participants
1 1
Creatinine: >159 μmol/L, n=396,410 Number Analyzed 396 participants 410 participants
20 16
Direct Bilirubin: >1.35 x ULN, n=396,410 Number Analyzed 396 participants 410 participants
0 1
Gamma Glutamyl Transferase: >3 x ULN, n=396,410 Number Analyzed 396 participants 410 participants
14 14
31.Secondary Outcome
Title Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26
Hide Description Urine samples were collected for analysis of albumin/creatinine ratio. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean urine albumin/creatinine ratio at Week 0 and Week 26 are presented.
Time Frame Week 0 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Mean (Standard Deviation)
Unit of Measure: Grams per mole
Week 0, n=369,376 Number Analyzed 369 participants 376 participants
14.40  (49.884) 11.57  (31.089)
Week 26, n=317,324 Number Analyzed 317 participants 324 participants
10.37  (32.992) 11.55  (31.975)
32.Secondary Outcome
Title Mean Albumin at Week 0 and Week 26
Hide Description Urine samples were collected for analysis of albumin. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean albumin at Week 0 and Week 26 are presented.
Time Frame Week 0 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Mean (Standard Deviation)
Unit of Measure: Milligrams per Liter
Week 0, n=394,405 Number Analyzed 394 participants 405 participants
127.7  (428.46) 108.2  (301.88)
Week 26, n=348,345 Number Analyzed 348 participants 345 participants
110.5  (375.41) 146.3  (628.73)
33.Secondary Outcome
Title Mean Creatinine at Week 0 and Week 26
Hide Description Urine samples were collected for analysis of creatinine. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean creatinine at Week 0 and Week 26 are presented.
Time Frame Week 0 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Mean (Standard Deviation)
Unit of Measure: Micromoles per Liter
Week 0, n=395,406 Number Analyzed 395 participants 406 participants
10646.3  (5190.43) 10663.8  (5639.54)
Week 26, n=350,345 Number Analyzed 350 participants 345 participants
11364.6  (5998.72) 11394.2  (5663.72)
34.Secondary Outcome
Title Mean Specific Gravity at Week 0 and Week 26
Hide Description Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney’s ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame Week 0 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 0, n=388,402 Number Analyzed 388 participants 402 participants
1.0182  (0.00599) 1.0180  (0.00588)
Week 26, n=347,343 Number Analyzed 347 participants 343 participants
1.0180  (0.00627) 1.0186  (0.00588)
35.Secondary Outcome
Title Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26
Hide Description Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Safety Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame Week 0 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
pH=5; Week 0, n=388,402 Number Analyzed 388 participants 402 participants
92 107
pH=5.5; Week 0, n=388,402 Number Analyzed 388 participants 402 participants
132 132
pH=6; Week 0, n=388,402 Number Analyzed 388 participants 402 participants
86 77
pH=6.5; Week 0, n=388,402 Number Analyzed 388 participants 402 participants
29 43
pH=7; Week 0, n=388,402 Number Analyzed 388 participants 402 participants
29 24
pH=7.5; Week 0, n=388,402 Number Analyzed 388 participants 402 participants
13 11
pH=8; Week 0, n=388,402 Number Analyzed 388 participants 402 participants
6 7
pH=8.5; Week 0, n=388,402 Number Analyzed 388 participants 402 participants
1 1
pH=5; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
80 100
pH=5.5; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
107 104
pH=6; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
69 70
pH=6.5; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
42 23
pH=7; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
19 23
pH=7.5; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
17 18
pH=8; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
7 5
pH=8.5; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
5 0
pH>9; Week 26, n=347,343 Number Analyzed 347 participants 343 participants
1 0
36.Secondary Outcome
Title Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26
Hide Description Urine samples were collected for analysis of erythrocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of erythrocytes in urine at Week 0 and Week 26 are presented.
Time Frame Week 0 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
None Seen; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
119 101
0 to 1; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
34 51
1 to 3; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
9 14
3 to 5; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
3 12
5 to 10; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
2 4
10 to 15; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
0 2
15 to 25; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
2 1
50 to 100; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
0 1
>100; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
2 1
None Seen; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
98 79
0 to 1; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
48 36
1 to 3; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
8 19
3 to 5; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
4 3
5 to 10; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
4 4
25 to 50; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
1 2
50 to 100; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
2 0
>100; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
1 1
37.Secondary Outcome
Title Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26
Hide Description Urine samples were collected for analysis of leukocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of leukocytes in urine at Week 0 and Week 26 are presented.
Time Frame Week 0 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Measure Type: Number
Unit of Measure: Participants
None Seen; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
69 67
0 to 1; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
27 31
1 to 3; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
20 18
3 to 5; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
16 13
5 to 10; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
17 19
10 to 15; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
7 6
15 to 25; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
5 11
25 to 50; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
5 11
50 to 100; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
1 7
>100; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
4 3
Innumerable; Week 0, n=171,187 Number Analyzed 171 participants 187 participants
0 1
None Seen; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
65 44
0 to 1; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
25 29
1 to 3; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
22 20
3 to 5; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
10 15
5 to 10; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
22 14
10 to 15; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
8 5
15 to 25; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
3 3
20 to 50; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
0 1
25 to 50; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
5 6
50 to 100; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
5 5
>100; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
1 1
Innumerable; Week 26, n=166,144 Number Analyzed 166 participants 144 participants
0 1
38.Secondary Outcome
Title Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26
Hide Description Lipid parameters included TC, LDL-c, HDL-c, TG and FFA. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. LDL-c and FFA were collected as part of the lipid panel and results were reviewed by investigators for individual participants. Change from Baseline at Week 10 and Week 26 was not assessed for these parameters. Analysis of these parameters was not a specific study objective and would not have any impact on study conclusions. Only those parameters with data values have been presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.
Time Frame Baseline, Week 10 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 400 413
Mean (Standard Deviation)
Unit of Measure: Millimoles per Liters
TC: Week 10, n=376,393 Number Analyzed 376 participants 393 participants
-0.244  (0.8047) 0.041  (0.7425)
TC: Week 26, n=348,351 Number Analyzed 348 participants 351 participants
-0.059  (0.8721) 0.073  (0.8232)
HDL-c: Week 10, n=376,393 Number Analyzed 376 participants 393 participants
-0.041  (0.1944) 0.016  (0.1810)
HDL-c: Week 26, n=348,351 Number Analyzed 348 participants 351 participants
-0.013  (0.2102) 0.005  (0.2138)
TG: Week 10, n=376,393 Number Analyzed 376 participants 393 participants
-0.039  (1.3563) -0.065  (0.8045)
TG: Week 26, n=348,351 Number Analyzed 348 participants 351 participants
0.025  (1.1949) -0.028  (0.9342)
39.Secondary Outcome
Title Number of Participants With Vital Signs of Clinical Concern
Hide Description Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values. Assessment of vitals were performed with the participant in a semi recumbent or seated position having rested in this position for at least 5 minutes before each reading. The potential clinical concern values were: SBP: <100 millimeters of mercury (mmHg) and >170 mmHg, DBP: <50 mmHg and >110 mmHg and pulse rate: <50 beats per minute (bpm) and > 120 bpm. Number of participants with vital signs of clinical concern are presented.
Time Frame Up to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 397 411
Measure Type: Number
Unit of Measure: Participants
SBP: < 100 mmHg 21 20
SBP: > 170 mmHg 27 30
DBP: < 50 mmHg 1 4
DBP: > 110 mmHg 1 5
Pulse Rate: < 50 bpm 4 9
Pulse Rate: > 120 bpm 3 1
40.Secondary Outcome
Title Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters
Hide Description A single 12-lead ECG recordings were performed in a participant in semi recumbent position for 10 to 15 minutes before obtaining the ECG. Any clinically significant favorable and unfavorable findings are reported.
Time Frame Up to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description:
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period.
During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
Overall Number of Participants Analyzed 384 394
Measure Type: Number
Unit of Measure: Participants
Clinically Significant Change: Favorable 18 9
Clinically Significant Change: Unfavorable 4 5
Time Frame Up to 26 weeks
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs were collected for Safety Population which comprised of all participants who receive at least 1 dose of randomized study medication.
 
Arm/Group Title Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Hide Arm/Group Description During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants received Albiglutide 30 mg weekly SC injection during the treatment period and insulin lispro dose was down-titrated to half that used in the standardization period. At Week 4, Albiglutide was up-titrated to 50 mg weekly SC injection and insulin lispro was stopped for the remainder of the treatment period. During standardization period, participants transitioned from basal bolus regimen received during screening period to insulin glargine plus insulin lispro. Eligible participants continued with the same doses as at the end of the standardization period and doses were adjusted according to protocol-defined insulin titration algorithms. Participants received Insulin Glargine along with Insulin Lispro during the treatment period.
All-Cause Mortality
Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/400 (0.00%)      1/413 (0.24%)    
Show Serious Adverse Events Hide Serious Adverse Events
Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/400 (5.75%)      31/413 (7.51%)    
Cardiac disorders     
Acute myocardial infarction  1  1/400 (0.25%)  1 2/413 (0.48%)  2
Angina unstable  1  1/400 (0.25%)  2 1/413 (0.24%)  1
Angina pectoris  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Atrial fibrillation  1  0/400 (0.00%)  0 1/413 (0.24%)  2
Atrial flutter  1  1/400 (0.25%)  2 0/413 (0.00%)  0
Atrioventricular block complete  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Cardiac failure congestive  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Ear and labyrinth disorders     
Conductive deafness  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Vertigo positional  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Eye disorders     
Angle closure glaucoma  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Gastrointestinal disorders     
Colitis  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Mesenteric artery stenosis  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Pancreatitis  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Rectal haemorrhage  1  0/400 (0.00%)  0 1/413 (0.24%)  1
General disorders     
Chest pain  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Non-cardiac chest pain  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Hepatobiliary disorders     
Cholecystitis acute  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Infections and infestations     
Pneumonia  1  1/400 (0.25%)  1 2/413 (0.48%)  2
Osteomyelitis  1  0/400 (0.00%)  0 2/413 (0.48%)  2
Appendicitis  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Gastroenteritis  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Influenza  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Pyelonephritis  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Injury, poisoning and procedural complications     
Ligament injury  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Multiple injuries  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Perineal injury  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Thoracic vertebral fracture  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/400 (0.00%)  0 6/413 (1.45%)  6
Diabetes mellitus  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Breast cancer  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Teratoma  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Nervous system disorders     
Syncope  1  1/400 (0.25%)  1 1/413 (0.24%)  1
Brain stem infarction  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Carpal tunnel syndrome  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Cerebrovascular accident  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Facial paralysis  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Hyperaesthesia  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Ischaemic stroke  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Sciatica  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Transient ischaemic attack  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Reproductive system and breast disorders     
Metrorrhagia  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Uterine polyp  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Vascular disorders     
Peripheral ischaemia  1  1/400 (0.25%)  1 1/413 (0.24%)  1
Hypertensive crisis  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Peripheral arterial occlusive disease  1  1/400 (0.25%)  1 0/413 (0.00%)  0
Peripheral artery stenosis  1  0/400 (0.00%)  0 1/413 (0.24%)  1
Peripheral vascular disorder  1  1/400 (0.25%)  1 0/413 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Albiglutide + Insulin Glargine Insulin Lispro + Insulin Glargine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   114/400 (28.50%)      101/413 (24.46%)    
Gastrointestinal disorders     
Diarrhoea  1  31/400 (7.75%)  51 18/413 (4.36%)  19
Nausea  1  37/400 (9.25%)  53 7/413 (1.69%)  7
Infections and infestations     
Influenza  1  24/400 (6.00%)  30 36/413 (8.72%)  42
Viral upper respiratory tract infection  1  25/400 (6.25%)  33 34/413 (8.23%)  39
Urinary tract infection  1  22/400 (5.50%)  25 23/413 (5.57%)  24
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02229227     History of Changes
Other Study ID Numbers: 200977
First Submitted: August 28, 2014
First Posted: September 1, 2014
Results First Submitted: June 1, 2018
Results First Posted: June 29, 2018
Last Update Posted: June 29, 2018