Trial Outcomes & Findings for Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4) (NCT NCT00676338)
NCT ID: NCT00676338
Last Updated: 2015-04-09
Results Overview
Change in HbA1c from baseline to Week 26.
COMPLETED
PHASE3
820 participants
Baseline, Week 26
2015-04-09
Participant Flow
Participant milestones
| Measure |
Exenatide Once Weekly
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
248
|
246
|
163
|
163
|
|
Overall Study
COMPLETED
|
210
|
213
|
133
|
140
|
|
Overall Study
NOT COMPLETED
|
38
|
33
|
30
|
23
|
Reasons for withdrawal
| Measure |
Exenatide Once Weekly
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
6
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
3
|
4
|
|
Overall Study
Physician Decision
|
3
|
3
|
2
|
3
|
|
Overall Study
Protocol Violation
|
5
|
9
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
17
|
9
|
12
|
6
|
|
Overall Study
Entry Criteria Not Met
|
0
|
2
|
1
|
1
|
|
Overall Study
Lack of Efficacy-Loss of Glucose Control
|
3
|
3
|
5
|
3
|
Baseline Characteristics
Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
Baseline characteristics by cohort
| Measure |
Exenatide Once Weekly
n=248 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=246 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=163 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=163 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
Total
n=820 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
217 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
711 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 11.08 • n=7 Participants
|
55.3 years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 11.05 • n=4 Participants
|
53.7 years
STANDARD_DEVIATION 11.02 • n=21 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
336 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
484 Participants
n=21 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
8.5 percentage of total hemoglobin
STANDARD_DEVIATION 1.19 • n=5 Participants
|
8.6 percentage of total hemoglobin
STANDARD_DEVIATION 1.20 • n=7 Participants
|
8.5 percentage of total hemoglobin
STANDARD_DEVIATION 1.24 • n=5 Participants
|
8.5 percentage of total hemoglobin
STANDARD_DEVIATION 1.25 • n=4 Participants
|
8.5 percentage of total hemoglobin
STANDARD_DEVIATION 1.22 • n=21 Participants
|
|
Weight
|
87.5 kg
STANDARD_DEVIATION 18.88 • n=5 Participants
|
85.9 kg
STANDARD_DEVIATION 19.57 • n=7 Participants
|
86.1 kg
STANDARD_DEVIATION 17.77 • n=5 Participants
|
88.7 kg
STANDARD_DEVIATION 18.65 • n=4 Participants
|
87.0 kg
STANDARD_DEVIATION 18.83 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Intent to treat (ITT) population consisted of all randomized patients who had taken at least one dose of study drug. All scheduled post-baseline measurements were included in the analysis. Unscheduled visit observations were carried forward to the next scheduled visits.
Change in HbA1c from baseline to Week 26.
Outcome measures
| Measure |
Exenatide Once Weekly
n=218 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=218 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=137 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=142 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline to Week 26
|
-1.53 percentage of total hemoglobin
Standard Error 0.07
|
-1.48 percentage of total hemoglobin
Standard Error 0.07
|
-1.63 percentage of total hemoglobin
Standard Error 0.08
|
-1.15 percentage of total hemoglobin
Standard Error 0.08
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: ITT subjects with baseline HbA1c\>7%. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.
Percentage of patients achieving HbA1c \<=7% at Week 26 (for patients with baseline HbA1c \>7%).
Outcome measures
| Measure |
Exenatide Once Weekly
n=226 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=232 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=150 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=143 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Percentage of Patients Achieving HbA1c <=7% at Week 26
|
64.2 percentage of patients
|
57.3 percentage of patients
|
63.3 percentage of patients
|
45.5 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.
Change in FSG from baseline to Week 26.
Outcome measures
| Measure |
Exenatide Once Weekly
n=198 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=203 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=127 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=120 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
|
-2.25 mmol/L
Standard Error 0.14
|
-1.98 mmol/L
Standard Error 0.14
|
-2.57 mmol/L
Standard Error 0.18
|
-1.13 mmol/L
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.
Change in Body Weight from baseline to Week 26.
Outcome measures
| Measure |
Exenatide Once Weekly
n=215 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=217 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=134 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=141 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Change in Body Weight From Baseline to Week 26
|
-2.04 kg
Standard Error 0.21
|
-2.00 kg
Standard Error 0.21
|
1.52 kg
Standard Error 0.26
|
-0.76 kg
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.
Change in Fasting TC from baseline to Week 26.
Outcome measures
| Measure |
Exenatide Once Weekly
n=199 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=203 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=127 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=120 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26
|
-0.24 mmol/L
Standard Error 0.06
|
-0.22 mmol/L
Standard Error 0.06
|
0.09 mmol/L
Standard Error 0.08
|
-0.01 mmol/L
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.
Change in Fasting HDL from baseline to Week 26.
Outcome measures
| Measure |
Exenatide Once Weekly
n=199 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=203 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=127 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=120 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26
|
0.01 mmol/L
Standard Error 0.01
|
0.07 mmol/L
Standard Error 0.01
|
0.17 mmol/L
Standard Error 0.02
|
0.04 mmol/L
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.
Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.
Outcome measures
| Measure |
Exenatide Once Weekly
n=200 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=204 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=127 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=121 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Ratio of Fasting Triglycerides at Week 26 to Baseline
|
0.98 ratio
Standard Error 0.03
|
0.96 ratio
Standard Error 0.03
|
0.85 ratio
Standard Error 0.03
|
0.94 ratio
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: ITT population.
Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Outcome measures
| Measure |
Exenatide Once Weekly
n=248 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=246 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=163 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=163 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: ITT population.
Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Outcome measures
| Measure |
Exenatide Once Weekly
n=248 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=246 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=163 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=163 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events
|
0.05 events per subject-year
Standard Error 0.021
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.
Change in Systolic Blood Pressure from baseline to Week 26.
Outcome measures
| Measure |
Exenatide Once Weekly
n=215 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=217 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=134 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=141 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to Week 26.
|
-1.25 mmHg
Standard Error 0.79
|
0.14 mmHg
Standard Error 0.78
|
-1.74 mmHg
Standard Error 0.98
|
-1.81 mmHg
Standard Error 0.96
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.
Change in Diastolic Blood Pressure from baseline to Week 26.
Outcome measures
| Measure |
Exenatide Once Weekly
n=215 Participants
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=217 Participants
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=134 Participants
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=141 Participants
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to Week 26.
|
-0.50 mmHg
Standard Error 0.51
|
-0.86 mmHg
Standard Error 0.50
|
-2.50 mmHg
Standard Error 0.63
|
-0.45 mmHg
Standard Error 0.62
|
Adverse Events
Exenatide Once Weekly
Metformin
Pioglitazone
Sitagliptin
Serious adverse events
| Measure |
Exenatide Once Weekly
n=248 participants at risk
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=246 participants at risk
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=163 participants at risk
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=163 participants at risk
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Renal and urinary disorders
Calculus ureteric
|
0.40%
1/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Dehydration
|
0.40%
1/248
|
0.00%
0/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.40%
1/248
|
0.00%
0/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.40%
1/248
|
0.00%
0/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.40%
1/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.40%
1/248
|
0.00%
0/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Vascular disorders
Arteritis
|
0.00%
0/248
|
0.00%
0/246
|
0.00%
0/163
|
0.61%
1/163
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Cellulitis
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
General disorders
Chest pain
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/248
|
0.00%
0/246
|
0.00%
0/163
|
0.61%
1/163
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
General disorders
Oedema
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/248
|
0.00%
0/246
|
0.00%
0/163
|
0.61%
1/163
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/248
|
0.41%
1/246
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Wound infection
|
0.00%
0/248
|
0.00%
0/246
|
0.61%
1/163
|
0.00%
0/163
|
Other adverse events
| Measure |
Exenatide Once Weekly
n=248 participants at risk
Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
|
Metformin
n=246 participants at risk
Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Pioglitazone
n=163 participants at risk
Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
|
Sitagliptin
n=163 participants at risk
Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.3%
28/248
|
6.9%
17/246
|
3.7%
6/163
|
3.7%
6/163
|
|
Gastrointestinal disorders
Diarrhoea
|
10.9%
27/248
|
12.6%
31/246
|
3.7%
6/163
|
5.5%
9/163
|
|
General disorders
Injection site nodule
|
10.5%
26/248
|
10.2%
25/246
|
3.7%
6/163
|
6.7%
11/163
|
|
Gastrointestinal disorders
Constipation
|
8.5%
21/248
|
3.3%
8/246
|
1.8%
3/163
|
2.5%
4/163
|
|
Nervous system disorders
Headache
|
8.1%
20/248
|
12.2%
30/246
|
8.0%
13/163
|
9.2%
15/163
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
19/248
|
4.5%
11/246
|
8.6%
14/163
|
9.8%
16/163
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
18/248
|
3.3%
8/246
|
4.9%
8/163
|
1.8%
3/163
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
13/248
|
1.2%
3/246
|
3.1%
5/163
|
1.8%
3/163
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
6/248
|
5.7%
14/246
|
4.3%
7/163
|
3.1%
5/163
|
|
Vascular disorders
Hypertension
|
1.2%
3/248
|
1.2%
3/246
|
7.4%
12/163
|
1.8%
3/163
|
|
General disorders
Oedema peripheral
|
0.00%
0/248
|
0.41%
1/246
|
7.4%
12/163
|
0.61%
1/163
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60