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Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8) (AWARD-8)

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ClinicalTrials.gov Identifier: NCT01769378
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : October 14, 2015
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Placebo
Drug: Dulaglutide
Drug: Glimepiride
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose. Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Period Title: Overall Study
Started 240 60
Received at Least 1 Dose of Study Drug 239 60
Completed 215 [1] 56 [1]
Not Completed 25 4
Reason Not Completed
Adverse Event             10             0
Entry criteria not met             1             0
Protocol Violation             1             1
Withdrawal by Subject             10             3
Sponsor Decision             1             0
Lost to Follow-up             2             0
[1]
Completed the study on study treatment
Arm/Group Title Dulaglutide Placebo Total
Hide Arm/Group Description Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose. Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose. Total of all reporting groups
Overall Number of Baseline Participants 239 60 299
Hide Baseline Analysis Population Description
Intent to treat (ITT) population: all randomized participants who received at least one dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 60 participants 299 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
182
  76.2%
49
  81.7%
231
  77.3%
>=65 years
57
  23.8%
11
  18.3%
68
  22.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 239 participants 60 participants 299 participants
57.73  (10.20) 58.23  (7.40) 57.83  (9.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 60 participants 299 participants
Female
135
  56.5%
32
  53.3%
167
  55.9%
Male
104
  43.5%
28
  46.7%
132
  44.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 60 participants 299 participants
Hispanic or Latino
112
  46.9%
27
  45.0%
139
  46.5%
Not Hispanic or Latino
127
  53.1%
33
  55.0%
160
  53.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 60 participants 299 participants
American Indian or Alaska Native
21
   8.8%
5
   8.3%
26
   8.7%
Asian
3
   1.3%
2
   3.3%
5
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   2.9%
4
   6.7%
11
   3.7%
White
202
  84.5%
47
  78.3%
249
  83.3%
More than one race
6
   2.5%
2
   3.3%
8
   2.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 239 participants 60 participants 299 participants
Argentina 29 8 37
Austria 4 1 5
Romania 78 18 96
United States 57 14 71
South Africa 7 3 10
Mexico 40 10 50
Slovenia 13 3 16
Croatia 9 2 11
Puerto Rico 2 1 3
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks
Hide Description Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data at both baseline and post-baseline.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 215 53
Least Squares Mean (Standard Error)
Unit of Measure: percent change of HbA1c
-1.38  (0.08) -0.11  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dulaglutide, Placebo
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 Squares Mean Difference
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-1.57 to -0.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks
Hide Description The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 215 53
Measure Type: Number
Unit of Measure: percentage of participants
Percent Achieved <7.0 HbA1c Level 55.3 18.9
Percent Achieved ≤6.5 HbA1c Level 40.0 9.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dulaglutide, Placebo
Comments <7.0% HbA1c
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Sequential gatekeeping strategy was used to adjust for multiplicity.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.37
Confidence Interval (2-Sided) 95%
3.82 to 33.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dulaglutide, Placebo
Comments ≤6.5% HbA1c
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.45
Confidence Interval (2-Sided) 95%
3.71 to 35.34
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks
Hide Description LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug and had evaluable FSG data at both baseline and post-baseline. LOCF was used to impute missing post-baseline values. If no data after date of randomization, the endpoint was considered missing.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 218 51
Least Squares Mean (Standard Error)
Unit of Measure: milligrams per deciliter (mg/dL)
-30.60  (4.46) 2.93  (6.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dulaglutide, Placebo
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 ANCOVA
Comments Sequential gatekeeping strategy was used to adjust for multiplicity.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -33.54
Confidence Interval (2-Sided) 95%
-46.55 to -20.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.60
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Body Weight at 24 Weeks
Hide Description LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML.
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug and had evaluable body weight data at both baseline and post-baseline.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 212 53
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
-0.91  (0.21) -0.24  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dulaglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequential gatekeeping strategy was used to adjust for multiplicity.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.53 to 0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.43
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Body Mass Index (BMI) at 24 Weeks
Hide Description LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML.
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug and evaluable BMI data at both baseline and post-baseline.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 212 53
Least Squares Mean (Standard Error)
Unit of Measure: kilograms per/square meter kg/m^2
-0.32  (0.08) -0.10  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dulaglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments No adjustment for multiplicity
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.54 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks
Hide Description LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug and had evaluable SMPG data at both baseline and post-baseline.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 203 49
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-37.22  (3.10) -8.27  (4.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dulaglutide, Placebo
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 Least Squares Mean Difference
Estimated Value -28.95
Confidence Interval (2-Sided) 95%
-38.49 to -19.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.85
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Reported and Adjudicated Cardiovascular Events
Hide Description Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.
Time Frame Baseline through 24 Weeks, 30-day Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who received at least one dose of study drug.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 239 60
Measure Type: Number
Unit of Measure: participants
Any reported CV events 2 0
Any adjudicated nonfatal CV events 2 0
Any confirmed adjudicated CV deaths 0 0
8.Secondary Outcome
Title Number of Participants With Adjudicated Acute Pancreatitis Events
Hide Description The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. 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 24 Weeks, 30-day Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received at least one dose of study drug.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 239 60
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Change From Baseline in Calcitonin at 24 Weeks
Hide Description [Not Specified]
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug and evaluable calcitonin data at baseline and post-baseline.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 215 59
Median (Inter-Quartile Range)
Unit of Measure: picogram per milliliter (pg/ml)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
10.Secondary Outcome
Title Percentage of Participants With Self-Reported Events of Hypoglycemia
Hide Description Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.
Time Frame Baseline through 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all randomized participants who received at least one dose of study drug.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 239 60
Measure Type: Number
Unit of Measure: percentage of participants
Symptomatic 11.3 1.7
Asymptomatic 13.4 1.7
Probable 2.5 0.0
Severe 0 0
Nocturnal 6.7 1.7
11.Secondary Outcome
Title Rate of HE Adjusted Per 30 Days
Hide Description The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.
Time Frame Baseline through 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received at least one dose of study drug.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 239 60
Mean (Standard Deviation)
Unit of Measure: number of events/participants/30 days
Total HE 0.19  (0.59) 0.01  (0.03)
Documented symptomatic HE 0.07  (0.33) 0.00  (0.02)
Asymptomatic HE 0.11  (0.45) 0.00  (0.02)
Severe HE 0  (0.0) 0  (0.0)
Nocturnal HE 0.02  (0.16) 0.00  (0.02)
Probable symptomatic HE 0.01  (0.04) 0  (0.0)
12.Secondary Outcome
Title Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia
Hide Description Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.
Time Frame Baseline through 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received at least one dose of study drug.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 239 60
Measure Type: Number
Unit of Measure: percentage of participants
2.1 11.7
13.Secondary Outcome
Title Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia
Hide Description An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.
Time Frame Baseline through 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized participants who received at least one dose of study drug.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 239 60
Mean (Standard Error)
Unit of Measure: weeks
22.59  (0.36) 22.47  (0.66)
14.Secondary Outcome
Title Dulaglutide Anti-Drug Antibodies (ADA)
Hide Description Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Time Frame Baseline up to 4 Weeks Post-Last Dose of Study Drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants who received at least one dose of study drug.
Arm/Group Title Dulaglutide
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 239
Measure Type: Number
Unit of Measure: participants
2
15.Secondary Outcome
Title Change From Baseline in Lipase
Hide Description A summary of changes in lipase evaluation from baseline to endpoint.
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable lipase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 233 60
Median (Inter-Quartile Range)
Unit of Measure: Units/Liter
8.0
(1.0 to 18.0)
4.5
(-2.5 to 15.5)
16.Secondary Outcome
Title Change From Baseline in Amylase
Hide Description A summary of changes in amylase evaluation from baseline to endpoint.
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug and had evaluable amylase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description:
Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
Overall Number of Participants Analyzed 233 60
Median (Inter-Quartile Range)
Unit of Measure: Units/Liter
8.0
(1.0 to 18.0)
2.0
(-5.0 to 11.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dulaglutide Placebo
Hide Arm/Group Description Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose. Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
All-Cause Mortality
Dulaglutide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dulaglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/239 (3.77%)      0/60 (0.00%)    
Cardiac disorders     
Angina pectoris  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Infections and infestations     
Osteomyelitis  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Otitis media  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Pulmonary tuberculosis  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Injury, poisoning and procedural complications     
Ulna fracture  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycemia  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anaplastic astrocytoma  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  1/239 (0.42%)  1 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dulaglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/239 (18.41%)      3/60 (5.00%)    
Gastrointestinal disorders     
Diarrhoea  1  20/239 (8.37%)  30 0/60 (0.00%)  0
Eructation  1  14/239 (5.86%)  24 0/60 (0.00%)  0
Nausea  1  25/239 (10.46%)  31 0/60 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycemia  1  1/239 (0.42%)  1 3/60 (5.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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
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Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01769378     History of Changes
Other Study ID Numbers: 13193
H9X-MC-GBDG ( Other Identifier: Eli Lilly and Company )
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: September 14, 2015
Results First Posted: October 14, 2015
Last Update Posted: January 25, 2016