Trial Outcomes & Findings for A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5) (NCT NCT00877890)
NCT ID: NCT00877890
Last Updated: 2015-04-07
Results Overview
Change in HbA1c from baseline (Day 1) to Week 24 \[Week 24 - Baseline\].
COMPLETED
PHASE3
254 participants
Day 1, Week 24
2015-04-07
Participant Flow
Participant milestones
| Measure |
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
125
|
|
Overall Study
Intent to Treat (ITT)
|
129
|
123
|
|
Overall Study
COMPLETED
|
109
|
95
|
|
Overall Study
NOT COMPLETED
|
20
|
30
|
Reasons for withdrawal
| Measure |
Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal of Consent
|
6
|
12
|
|
Overall Study
Investigator Decision
|
0
|
2
|
|
Overall Study
Loss of Glucose Control
|
3
|
4
|
Baseline Characteristics
A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)
Baseline characteristics by cohort
| Measure |
Exenatide Once Weekly
n=129 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=123 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=39 Participants
|
102 Participants
n=41 Participants
|
205 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 11.14 • n=39 Participants
|
55.2 years
STANDARD_DEVIATION 10.27 • n=41 Participants
|
55.7 years
STANDARD_DEVIATION 10.71 • n=35 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=39 Participants
|
55 Participants
n=41 Participants
|
107 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=39 Participants
|
68 Participants
n=41 Participants
|
145 Participants
n=35 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
8.5 percentage of total hemoglobin
STANDARD_DEVIATION 1.10 • n=39 Participants
|
8.4 percentage of total hemoglobin
STANDARD_DEVIATION 1.23 • n=41 Participants
|
8.4 percentage of total hemoglobin
STANDARD_DEVIATION 1.16 • n=35 Participants
|
|
Weight
|
97.0 kg
STANDARD_DEVIATION 20.66 • n=39 Participants
|
94.3 kg
STANDARD_DEVIATION 18.94 • n=41 Participants
|
95.7 kg
STANDARD_DEVIATION 19.85 • n=35 Participants
|
|
Background Oral Antidiabetic Agent
Diet and Exercise
|
21 participants
n=39 Participants
|
26 participants
n=41 Participants
|
47 participants
n=35 Participants
|
|
Background Oral Antidiabetic Agent
Metformin (MET)
|
51 participants
n=39 Participants
|
52 participants
n=41 Participants
|
103 participants
n=35 Participants
|
|
Background Oral Antidiabetic Agent
Sulfonylurea (SU)
|
1 participants
n=39 Participants
|
8 participants
n=41 Participants
|
9 participants
n=35 Participants
|
|
Background Oral Antidiabetic Agent
Thiazolidinediones (TZD)
|
4 participants
n=39 Participants
|
2 participants
n=41 Participants
|
6 participants
n=35 Participants
|
|
Background Oral Antidiabetic Agent
MET+SU
|
34 participants
n=39 Participants
|
25 participants
n=41 Participants
|
59 participants
n=35 Participants
|
|
Background Oral Antidiabetic Agent
MET+TZD
|
13 participants
n=39 Participants
|
9 participants
n=41 Participants
|
22 participants
n=35 Participants
|
|
Background Oral Antidiabetic Agent
SU+MET+TZD
|
5 participants
n=39 Participants
|
1 participants
n=41 Participants
|
6 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 1, Week 24Population: The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 24 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in HbA1c from baseline (Day 1) to Week 24 \[Week 24 - Baseline\].
Outcome measures
| Measure |
Exenatide Once Weekly
n=126 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=116 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline to Week 24
|
-1.57 percentage of total hemoglobin
Standard Error 0.104 • Interval -1.77 to -1.36
|
-0.90 percentage of total hemoglobin
Standard Error 0.110 • Interval -1.12 to -0.69
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Percentages of subjects achieving HbA1c target value of \<7% at Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=129 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=123 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of <7%
|
58.1 percentage of subjects
|
30.1 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=129 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=123 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of <=6.5%
|
41.1 percentage of subjects
|
16.3 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in fasting plasma glucose from baseline (Day 1) to Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=127 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=117 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline to Week 24
|
-25.1 mg/dL
Standard Error 4.32 • Interval -33.6 to -16.6
|
-4.6 mg/dL
Standard Error 4.50 • Interval -13.5 to 4.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=129 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=123 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL
|
50.4 percentage of subjects
|
30.9 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in body weight from baseline (Day 1) to Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=128 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=120 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Change in Body Weight From Baseline to Week 24
|
-2.33 kg
Standard Error 0.369 • Interval -3.05 to -1.6
|
-1.37 kg
Standard Error 0.386 • Interval -2.13 to -0.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in systolic blood pressure from baseline (Day 1) to Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=128 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=120 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Change in Sitting Systolic Blood Pressure From Baseline to Week 24
|
-2.9 mmHg
Standard Error 1.13 • Interval -5.2 to -0.7
|
-1.2 mmHg
Standard Error 1.19 • Interval -3.5 to 1.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in diastolic blood pressure from baseline (Day 1) to Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=128 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=120 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Change in Sitting Diastolic Blood Pressure From Baseline to Week 24
|
0.2 mmHg
Standard Error 0.74 • Interval -1.3 to 1.6
|
-0.1 mmHg
Standard Error 0.78 • Interval -1.7 to 1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in total cholesterol from baseline (Day 1) to Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=119 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=104 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Change in Total Cholesterol From Baseline to Week 24
|
-15.4 mg/dL
Standard Error 2.61 • Interval -20.5 to -10.2
|
0.6 mg/dL
Standard Error 2.79 • Interval -4.9 to 6.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in HDL from baseline (Day 1) to Week 24.
Outcome measures
| Measure |
Exenatide Once Weekly
n=119 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=104 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Change in High-density Lipoprotein (HDL) From Baseline to Week 24
|
0.0 mg/dL
Standard Error 0.60 • Interval -1.2 to 1.2
|
1.3 mg/dL
Standard Error 0.64 • Interval 0.0 to 2.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Week 24Population: ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Outcome measures
| Measure |
Exenatide Once Weekly
n=119 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=104 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Ratio of Triglycerides at Week 24 to Baseline
|
0.94 ratio
Standard Error 0.032 • Interval 0.88 to 1.0
|
0.99 ratio
Standard Error 0.036 • Interval 0.92 to 1.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Week 24Population: ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.
The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.
Outcome measures
| Measure |
Exenatide Once Weekly
n=40 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=34 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
n=89 Participants
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
n=89 Participants
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
|
0.00 rate per subject-year
Standard Error 0.000
|
0.00 rate per subject-year
Standard Error 0.000
|
0.00 rate per subject-year
Standard Error 0.000
|
0.00 rate per subject-year
Standard Error 0.000
|
SECONDARY outcome
Timeframe: Day 1 to Week 24Population: ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.
The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Outcome measures
| Measure |
Exenatide Once Weekly
n=40 Participants
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=34 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
Exenatide Once Weekly No SU
n=89 Participants
Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
|
Exenatide Twice Daily No SU
n=89 Participants
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
|
|---|---|---|---|---|
|
Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
|
0.75 rate per subject-year
Standard Error 0.217
|
0.31 rate per subject-year
Standard Error 0.153
|
0.00 rate per subject-year
Standard Error 0.000
|
0.00 rate per subject-year
Standard Error 0.000
|
Adverse Events
Exenatide Once Weekly
Exenatide Twice Daily
Serious adverse events
| Measure |
Exenatide Once Weekly
n=129 participants at risk
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=123 participants at risk
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
|---|---|---|
|
Renal and urinary disorders
Calculus ureteric
|
0.78%
1/129
|
0.00%
0/123
|
|
Infections and infestations
Cellulitis
|
0.78%
1/129
|
0.00%
0/123
|
|
Gastrointestinal disorders
Pancreatitis
|
0.78%
1/129
|
0.00%
0/123
|
|
General disorders
Chest pain
|
0.00%
0/129
|
0.81%
1/123
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/129
|
0.81%
1/123
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/129
|
0.81%
1/123
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/129
|
0.81%
1/123
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/129
|
0.81%
1/123
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/129
|
0.81%
1/123
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/129
|
0.81%
1/123
|
Other adverse events
| Measure |
Exenatide Once Weekly
n=129 participants at risk
Subcutaneous injection of 2 mg exenatide, once a week
|
Exenatide Twice Daily
n=123 participants at risk
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.0%
18/129
|
35.0%
43/123
|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
12/129
|
4.1%
5/123
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
9/129
|
4.1%
5/123
|
|
General disorders
Injection site erythema
|
5.4%
7/129
|
2.4%
3/123
|
|
Nervous system disorders
Headache
|
4.7%
6/129
|
8.1%
10/123
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
6/129
|
8.9%
11/123
|
|
Nervous system disorders
Dizziness
|
2.3%
3/129
|
6.5%
8/123
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60