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Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00765817
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : January 26, 2011
Last Update Posted : October 24, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: placebo
Drug: exenatide
Enrollment 261
Recruitment Details  
Pre-assignment Details Two subjects who started the study, subsequently withdrew prior to receiving study medication and are not part of the full analysis set
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents) Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Period Title: Overall Study
Started 138 [1] 123 [1]
Completed 112 101
Not Completed 26 22
Reason Not Completed
Adverse Event             13             1
Death             0             1
Entry criteria not met             2             2
Loss of glucose control             0             2
Lost to Follow-up             1             3
Physician Decision             2             1
Protocol Violation             1             1
Subject decision             7             11
[1]
One subject withdrew prior to receiving study medication, not included in analysis set
Arm/Group Title Exenatide Arm Placebo Arm Total
Hide Arm/Group Description Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents) Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents) Total of all reporting groups
Overall Number of Baseline Participants 137 122 259
Hide Baseline Analysis Population Description
One subject per group withdrew from the study prior to the first dose of study medication and therefore are not part of the baseline or subsequent analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 122 participants 259 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
100
  73.0%
84
  68.9%
184
  71.0%
>=65 years
37
  27.0%
38
  31.1%
75
  29.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants 122 participants 259 participants
58.67  (8.91) 59.40  (9.96) 59.01  (9.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants 122 participants 259 participants
Female
67
  48.9%
44
  36.1%
111
  42.9%
Male
70
  51.1%
78
  63.9%
148
  57.1%
1.Primary Outcome
Title Change in Glycosylated Hemoglobin (HbA1c)
Hide Description Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 112 100
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-1.71  (0.09) -1.00  (0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
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 [Not Specified]
2.Secondary Outcome
Title Percentage of Patients Achieving HbA1c <=7%
Hide Description Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 127 106
Measure Type: Number
Unit of Measure: percentage
58.3 31.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients Achieving HbA1c <=6.5%
Hide Description Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 131 113
Measure Type: Number
Unit of Measure: percentage
42.0 13.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change in Fasting Serum Glucose
Hide Description Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 111 98
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.28  (0.2) -0.87  (0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Hide Description Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 108 89
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
Pre-breakfast: baseline 7.89  (0.2) 8.27  (0.2)
Pre-breakfast: change at week 30 -1.58  (0.1) -1.48  (0.1)
2 hour post-breakfast: baseline 10.89  (0.2) 11.82  (0.2)
2 hour post-breakfast: change at week 30 -3.56  (0.2) -1.72  (0.2)
Pre-lunch: baseline 8.95  (0.2) 9.77  (0.2)
Pre-lunch: change at week 30 -2.23  (0.2) -1.15  (0.2)
2 hour post-lunch: baseline 11.35  (0.2) 11.70  (0.2)
2 hour post-lunch: change at week 30 -2.74  (0.2) -1.38  (0.2)
Pre-dinner: baseline 9.85  (0.2) 9.99  (0.2)
Pre-dinner: change at week 30 -2.25  (0.2) -1.33  (0.2)
2 hour post-dinner: baseline 12.03  (0.3) 11.86  (0.3)
2 hour post-dinner: change at week 30 -3.87  (0.2) -1.34  (0.3)
0300: baseline 8.95  (0.2) 9.20  (0.2)
0300: change at week 30 -2.27  (0.2) -1.48  (0.2)
6.Secondary Outcome
Title Change in Total Cholesterol
Hide Description Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 110 98
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.16  (0.08) -0.02  (0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change in Low Density Lipoprotein (LDL) Cholesterol
Hide Description Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 102 97
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.19  (0.07) -0.00  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in High Density Lipoprotein (HDL) Cholesterol
Hide Description Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 110 98
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.01  (0.02) 0.00  (0.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change in Triglycerides
Hide Description Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 110 98
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.02  (0.09) -0.03  (0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.933
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Change in Body Weight
Hide Description Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 112 101
Least Squares Mean (Standard Error)
Unit of Measure: kg
-1.78  (0.3) 0.96  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
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 [Not Specified]
11.Secondary Outcome
Title Change in Waist Circumference
Hide Description Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 137 120
Least Squares Mean (Standard Error)
Unit of Measure: cm
-1.08  (0.52) -0.25  (0.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.226
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Change in Daily Insulin Dose
Hide Description Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 110 100
Least Squares Mean (Standard Error)
Unit of Measure: insulin units (U)
13.19  (2.02) 19.71  (2.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change in Daily Insulin Dose (on a Per Body Weight Basis)
Hide Description Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 110 100
Least Squares Mean (Standard Error)
Unit of Measure: insulin units per kg (U/kg)
0.15  (0.02) 0.20  (0.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Change in Systolic Blood Pressure (SBP)
Hide Description Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 112 101
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-2.74  (1.2) 1.71  (1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
15.Secondary Outcome
Title Change in Diastolic Blood Pressure (DBP)
Hide Description Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
Time Frame baseline and 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 112 101
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-1.73  (0.6) 1.69  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
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 [Not Specified]
16.Secondary Outcome
Title Minor Hypoglycemia Rate Per Year
Hide Description Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
Time Frame baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 137 122
Mean (Standard Deviation)
Unit of Measure: events per subject per year
1.61  (5.94) 1.55  (4.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.666
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Subjects Experiencing Minor Hypoglycemia
Hide Description Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
Time Frame baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description:
Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
Overall Number of Participants Analyzed 137 122
Measure Type: Number
Unit of Measure: percentage
24.8 28.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide Arm Placebo Arm
Hide Arm/Group Description Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents) Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
All-Cause Mortality
Exenatide Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Exenatide Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   8/137 (5.84%)   11/122 (9.02%) 
Cardiac disorders     
Angina unstable * 1  0/137 (0.00%)  1/122 (0.82%) 
Coronary artery occlusion * 1  1/137 (0.73%)  0/122 (0.00%) 
Myocardial infarction * 1  0/137 (0.00%)  1/122 (0.82%) 
Palpitations * 1  0/137 (0.00%)  1/122 (0.82%) 
Transient ischemic attack * 1  0/137 (0.00%)  1/122 (0.82%) 
Gastrointestinal disorders     
Small intestine obstruction * 1  0/137 (0.00%)  1/122 (0.82%) 
General disorders     
Chest pain * 1  1/137 (0.73%)  1/122 (0.82%) 
Infections and infestations     
Herpes zoster * 1  1/137 (0.73%)  0/122 (0.00%) 
Sepsis * 1  0/137 (0.00%)  1/122 (0.82%) 
Staphylococcal infection * 1  1/137 (0.73%)  0/122 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  1/137 (0.73%)  0/122 (0.00%) 
Ankle fracture * 1  0/137 (0.00%)  1/122 (0.82%) 
Eye penetration * 1  1/137 (0.73%)  0/122 (0.00%) 
Fall * 1  1/137 (0.73%)  0/122 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycemia * 1  0/137 (0.00%)  1/122 (0.82%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  2/137 (1.46%)  0/122 (0.00%) 
Psychiatric disorders     
Suicide attempt * 1  0/137 (0.00%)  1/122 (0.82%) 
Renal and urinary disorders     
Cystitis * 1  0/137 (0.00%)  1/122 (0.82%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  1/137 (0.73%)  0/122 (0.00%) 
Pulmonary embolism * 1  0/137 (0.00%)  1/122 (0.82%) 
Skin and subcutaneous tissue disorders     
Uticaria * 1  0/137 (0.00%)  1/122 (0.82%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   109/138 (78.99%)   66/123 (53.66%) 
Gastrointestinal disorders     
Nausea * 1  56/138 (40.58%)  10/123 (8.13%) 
Diarrhea * 1  25/138 (18.12%)  10/123 (8.13%) 
Vomiting * 1  25/138 (18.12%)  5/123 (4.07%) 
Constipation * 1  14/138 (10.14%)  2/123 (1.63%) 
Dyspepsia * 1  9/138 (6.52%)  2/123 (1.63%) 
General disorders     
Asthenia * 1  7/138 (5.07%)  1/123 (0.81%) 
Infections and infestations     
Nasopharyngitis * 1  8/138 (5.80%)  6/123 (4.88%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  9/138 (6.52%)  2/123 (1.63%) 
Nervous system disorders     
Headache * 1  19/138 (13.77%)  5/123 (4.07%) 
Dizziness * 1  6/138 (4.35%)  7/123 (5.69%) 
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Tract Infection * 1  11/138 (7.97%)  9/123 (7.32%) 
Cough * 1  7/138 (5.07%)  7/123 (5.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
[Not Specified]
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: Peter Ohman, Medical Science Director
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00765817    
Other Study ID Numbers: H8O-US-GWCO
First Submitted: October 1, 2008
First Posted: October 3, 2008
Results First Submitted: January 4, 2011
Results First Posted: January 26, 2011
Last Update Posted: October 24, 2016