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A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01584232
Recruitment Status : Completed
First Posted : April 24, 2012
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: LY2189265
Drug: Insulin glargine
Drug: Sulfonylureas (SU)
Drug: Biguanide (BG)
Enrollment 361
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM
Hide Arm/Group Description

LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Period Title: Overall Study
Started 181 180
Received at Least 1 Dose of Study Drug 181 180
Completed 173 177
Not Completed 8 3
Reason Not Completed
Adverse Event             3             1
Withdrawal by Subject             2             1
Physician Decision             2             1
Lost to Follow-up             1             0
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM Total
Hide Arm/Group Description

LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Total of all reporting groups
Overall Number of Baseline Participants 181 180 361
Hide Baseline Analysis Population Description
All randomized participants who received at least 1 dose of LY2189265 or insulin glargine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants 180 participants 361 participants
57.52  (10.48) 56.14  (11.33) 56.83  (10.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 180 participants 361 participants
Female
56
  30.9%
47
  26.1%
103
  28.5%
Male
125
  69.1%
133
  73.9%
258
  71.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 181 participants 180 participants 361 participants
181 180 361
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 181 participants 180 participants 361 participants
181 180 361
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
Hide Description Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used.
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM
Hide Arm/Group Description:

LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Overall Number of Participants Analyzed 178 179
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
-1.44  (0.05) -0.90  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments Approximately 360 participants were to be randomized in a 1:1 ratio to LY2189265 or insulin glargine (IG). Assuming no difference in HbA1c change from baseline at Week 26 between LY2189265 and IG, this sample size would provide approximately 90% power to confirm non-inferiority of LY2189265 to IG. This computation was based on a non-inferiority margin of 0.4% with a standard deviation of 1.1%, a 1-sided alpha level of 0.025, and an 11% dropout rate between randomization and Week 26.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the 95% Confidence Interval (CI) was <0.4%, then LY2189265 was declared non-inferior to insulin glargine. If the upper limit of the 95% CI was <0.0%, then LY2189265 was declared superior to insulin glargine.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from the pairwise comparison of LS means using a mixed effects model with repeated measurements (MMRM).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.67 to -0.41
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks
Hide Description The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
Time Frame Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM
Hide Arm/Group Description:

LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Overall Number of Participants Analyzed 178 179
Measure Type: Number
Unit of Measure: percentage of participants
HbA1c <=6.5% 51.1 24.0
HbA1c <7% 71.3 45.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment comparison for HbA1c <=6.5%.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment comparison for HbA1c <7%.
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
Hide Description Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM
Hide Arm/Group Description:

LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Overall Number of Participants Analyzed 176 176
Least Squares Mean (Standard Error)
Unit of Measure: milligrams per deciliter (mg/dL)
-34.3  (1.9) -37.8  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
-1.7 to 8.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Hide Description Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects and baseline SMBG as a covariate.
Time Frame Baseline, Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM
Hide Arm/Group Description:

LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Overall Number of Participants Analyzed 178 179
Least Squares Mean (Standard Error)
Unit of Measure: milligrams per deciliter (mg/dL)
Pre-morning meal (n=178, 179) -33.49  (1.65) -38.66  (1.64)
2 hours post-morning meal (n=178, 179) -49.54  (3.33) -36.14  (3.31)
Pre-midday meal (n=178, 179) -36.16  (2.68) -27.94  (2.66)
2 hours post-midday meal (n=178, 179) -43.51  (3.27) -20.30  (3.25)
Pre-evening meal (n=178, 179) -31.14  (2.77) -17.50  (2.75)
2 hours post-evening meal (n=177, 178) -46.68  (3.05) -15.55  (3.03)
Bedtime (n=177, 172) -41.53  (2.95) -17.79  (2.96)
Second pre-morning meal (n=178, 179) -30.81  (1.60) -37.02  (1.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments Treatment comparison for pre-morning meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.16
Confidence Interval (2-Sided) 95%
0.76 to 9.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Treatment comparison for 2 hours post-morning meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -13.40
Confidence Interval (2-Sided) 95%
-22.28 to -4.52
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments Treatment comparison for pre-midday meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.22
Confidence Interval (2-Sided) 95%
-15.37 to -1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment comparison for 2 hours post-midday meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -23.22
Confidence Interval (2-Sided) 95%
-31.92 to -14.51
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment comparison for pre-evening meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -13.63
Confidence Interval (2-Sided) 95%
-21.03 to -6.24
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment comparison for 2 hours post-evening meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -31.13
Confidence Interval (2-Sided) 95%
-39.26 to -23.00
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment comparison for bedtime.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -23.73
Confidence Interval (2-Sided) 95%
-31.68 to -15.79
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments Treatment comparison for second pre-morning meal.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.21
Confidence Interval (2-Sided) 95%
1.92 to 10.50
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Body Weight at 26 Weeks
Hide Description Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.
Time Frame Baseline, 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable body weight data. Only pre-rescue measurements were used.
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM
Hide Arm/Group Description:

LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Overall Number of Participants Analyzed 180 180
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
-0.48  (0.17) 0.94  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.42
Confidence Interval (2-Sided) 95%
-1.89 to -0.94
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Hypoglycemic Episodes
Hide Description The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame Baseline through 26 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine. Only pre-rescue data was used.
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM
Hide Arm/Group Description:

LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Overall Number of Participants Analyzed 181 180
Measure Type: Number
Unit of Measure: percentage of participants
26.0 47.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2189265 + OAM, Insulin Glargine + OAM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2189265 + OAM Insulin Glargine + OAM
Hide Arm/Group Description

LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks

Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

All-Cause Mortality
LY2189265 + OAM Insulin Glargine + OAM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2189265 + OAM Insulin Glargine + OAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/181 (4.97%)      3/180 (1.67%)    
Cardiac disorders     
Acute myocardial infarction  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Hyperplastic cholecystopathy  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Infections and infestations     
Anal abscess  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Urinary tract infection  1  1/181 (0.55%)  2 0/180 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Patella fracture  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon neoplasm  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Liver carcinoma ruptured  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  2/181 (1.10%)  2 0/180 (0.00%)  0
Spinal cord infarction  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Viith nerve paralysis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Renal and urinary disorders     
Calculus ureteric  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LY2189265 + OAM Insulin Glargine + OAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   133/181 (73.48%)      111/180 (61.67%)    
Blood and lymphatic system disorders     
Anaemia  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Iron deficiency anaemia  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Cardiac disorders     
Angina pectoris  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Bundle branch block right  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Palpitations  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Supraventricular tachycardia  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Ear and labyrinth disorders     
Vertigo  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Vertigo positional  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Eye disorders     
Age-related macular degeneration  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Asthenopia  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Cataract  1  1/181 (0.55%)  1 1/180 (0.56%)  1
Conjunctival haemorrhage  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Conjunctivitis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Conjunctivitis allergic  1  2/181 (1.10%)  2 1/180 (0.56%)  1
Cystoid macular oedema  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Diabetic retinopathy  1  4/181 (2.21%)  4 2/180 (1.11%)  2
Dry eye  1  1/181 (0.55%)  1 1/180 (0.56%)  1
Eyelid ptosis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Keratitis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Macular degeneration  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Macular oedema  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Photopsia  1  0/181 (0.00%)  0 1/180 (0.56%)  2
Retinal vein occlusion  1  1/181 (0.55%)  1 1/180 (0.56%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  2/181 (1.10%)  13 0/180 (0.00%)  0
Abdominal distension  1  4/181 (2.21%)  5 1/180 (0.56%)  1
Abdominal pain  1  3/181 (1.66%)  6 0/180 (0.00%)  0
Abdominal pain lower  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Abdominal pain upper  1  3/181 (1.66%)  3 0/180 (0.00%)  0
Constipation  1  16/181 (8.84%)  19 6/180 (3.33%)  7
Dental caries  1  3/181 (1.66%)  3 4/180 (2.22%)  4
Diarrhoea  1  22/181 (12.15%)  31 4/180 (2.22%)  4
Dyspepsia  1  4/181 (2.21%)  6 0/180 (0.00%)  0
Enterocolitis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Epigastric discomfort  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Gastritis  1  2/181 (1.10%)  2 4/180 (2.22%)  4
Gastritis atrophic  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Gastrointestinal motility disorder  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Gastrooesophageal reflux disease  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Haemorrhoids  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Nausea  1  17/181 (9.39%)  27 2/180 (1.11%)  2
Periodontal disease  1  1/181 (0.55%)  1 1/180 (0.56%)  1
Toothache  1  1/181 (0.55%)  1 3/180 (1.67%)  3
Vomiting  1  9/181 (4.97%)  13 2/180 (1.11%)  2
General disorders     
Chest pain  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Chills  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Fatigue  1  0/181 (0.00%)  0 2/180 (1.11%)  2
Feeling abnormal  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Infusion site induration  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Injection site bruising  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Injection site dermatitis  1  1/181 (0.55%)  21 0/180 (0.00%)  0
Injection site hypersensitivity  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Injection site pruritus  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Malaise  1  0/181 (0.00%)  0 1/180 (0.56%)  2
Oedema  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Oedema due to renal disease  1  0/181 (0.00%)  0 1/180 (0.56%)  2
Oedema peripheral  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Hepatobiliary disorders     
Cholelithiasis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Gallbladder polyp  1  1/181 (0.55%)  1 1/180 (0.56%)  1
Hepatic calcification  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Hepatic cyst  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Hepatic steatosis  1  3/181 (1.66%)  3 3/180 (1.67%)  3
Immune system disorders     
Seasonal allergy  1  1/181 (0.55%)  1 2/180 (1.11%)  2
Infections and infestations     
Abscess oral  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Bacterial diarrhoea  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Bronchitis  1  4/181 (2.21%)  4 7/180 (3.89%)  10
Bronchopulmonary aspergillosis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Cystitis  1  2/181 (1.10%)  2 0/180 (0.00%)  0
Enteritis infectious  1  2/181 (1.10%)  2 2/180 (1.11%)  2
Enterocolitis bacterial  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Gastroenteritis  1  4/181 (2.21%)  4 3/180 (1.67%)  3
Gastroenteritis bacterial  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Gastroenteritis viral  1  0/181 (0.00%)  0 2/180 (1.11%)  2
Gingivitis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Helicobacter infection  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Herpes zoster  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Hordeolum  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Impetigo  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Influenza  1  6/181 (3.31%)  6 2/180 (1.11%)  2
Laryngitis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Lymphadenitis bacterial  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Mastitis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Nasopharyngitis  1  49/181 (27.07%)  55 46/180 (25.56%)  57
Oral herpes  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Periodontitis  1  3/181 (1.66%)  3 0/180 (0.00%)  0
Pharyngitis  1  4/181 (2.21%)  4 4/180 (2.22%)  4
Pyelonephritis acute  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Sinusitis  1  0/181 (0.00%)  0 2/180 (1.11%)  2
Subcutaneous abscess  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Tinea infection  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Tinea pedis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Tonsillitis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Upper respiratory tract infection  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Upper respiratory tract infection bacterial  1  2/181 (1.10%)  3 1/180 (0.56%)  1
Urinary tract infection  1  2/181 (1.10%)  3 0/180 (0.00%)  0
Injury, poisoning and procedural complications     
Arthropod sting  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Contusion  1  3/181 (1.66%)  3 1/180 (0.56%)  1
Foot fracture  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Joint injury  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Ligament sprain  1  1/181 (0.55%)  1 4/180 (2.22%)  6
Thermal burn  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Investigations     
Amylase increased  1  3/181 (1.66%)  3 0/180 (0.00%)  0
Blood creatine phosphokinase increased  1  0/181 (0.00%)  0 2/180 (1.11%)  2
Blood pressure increased  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Blood urea increased  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Blood urine present  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Heart rate increased  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Lipase increased  1  9/181 (4.97%)  9 1/180 (0.56%)  1
Occult blood  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Weight decreased  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  5/181 (2.76%)  6 0/180 (0.00%)  0
Dyslipidaemia  1  0/181 (0.00%)  0 2/180 (1.11%)  2
Hyperuricaemia  1  0/181 (0.00%)  0 2/180 (1.11%)  2
Hyponatraemia  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/181 (1.10%)  2 3/180 (1.67%)  3
Arthritis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Back pain  1  5/181 (2.76%)  5 5/180 (2.78%)  5
Bursitis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Intervertebral disc protrusion  1  3/181 (1.66%)  3 0/180 (0.00%)  0
Limb discomfort  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Muscle spasms  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Musculoskeletal pain  1  2/181 (1.10%)  2 1/180 (0.56%)  1
Myalgia  1  1/181 (0.55%)  2 0/180 (0.00%)  0
Osteoarthritis  1  1/181 (0.55%)  1 1/180 (0.56%)  1
Sensation of heaviness  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Spinal column stenosis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Spinal ligament ossification  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Tenosynovitis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Nervous system disorders     
Carotid arteriosclerosis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Cerebellar infarction  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Cervicobrachial syndrome  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Diabetic neuropathy  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Dizziness  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Headache  1  3/181 (1.66%)  8 0/180 (0.00%)  0
Hypoaesthesia  1  0/181 (0.00%)  0 2/180 (1.11%)  2
Vith nerve paralysis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Psychiatric disorders     
Alcohol problem  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Insomnia  1  3/181 (1.66%)  3 2/180 (1.11%)  2
Mental disorder  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Renal and urinary disorders     
Calculus ureteric  1  2/181 (1.10%)  2 0/180 (0.00%)  0
Calculus urinary  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Diabetic nephropathy  1  2/181 (1.10%)  2 1/180 (0.56%)  1
Dysuria  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Renal cyst  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/125 (0.80%)  1 1/133 (0.75%)  1
Endometriosis  1  1/56 (1.79%)  1 0/47 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/181 (0.55%)  1 1/180 (0.56%)  1
Hiccups  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Oropharyngeal pain  1  2/181 (1.10%)  2 1/180 (0.56%)  1
Rhinitis allergic  1  1/181 (0.55%)  1 2/180 (1.11%)  2
Sleep apnoea syndrome  1  0/181 (0.00%)  0 2/180 (1.11%)  2
Upper respiratory tract inflammation  1  1/181 (0.55%)  1 2/180 (1.11%)  2
Skin and subcutaneous tissue disorders     
Acne  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Asteatosis  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Dermatitis  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Dermatitis contact  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Eczema  1  5/181 (2.76%)  5 4/180 (2.22%)  5
Eczema asteatotic  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Prurigo  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Pruritus  1  2/181 (1.10%)  2 0/180 (0.00%)  0
Rash  1  2/181 (1.10%)  2 0/180 (0.00%)  0
Urticaria chronic  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Surgical and medical procedures     
Percutaneous coronary intervention  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Tooth extraction  1  1/181 (0.55%)  1 0/180 (0.00%)  0
Vascular disorders     
Hot flush  1  0/181 (0.00%)  0 1/180 (0.56%)  1
Hypertension  1  6/181 (3.31%)  6 6/180 (3.33%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01584232     History of Changes
Other Study ID Numbers: 14359
H9X-JE-GBDY ( Other Identifier: Eli Lilly and Company )
First Submitted: April 23, 2012
First Posted: April 24, 2012
Results First Submitted: October 3, 2014
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014