Trial Outcomes & Findings for Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin (NCT NCT00701935)
NCT ID: NCT00701935
Last Updated: 2015-04-10
Results Overview
Percentage change in abdominal visceral fat
TERMINATED
PHASE2
80 participants
baseline, 6 months
2015-04-10
Participant Flow
Initial planned enrolment was 12 months, starting August 2008. Eventual enrolment time was 3+ years - decision made to close end of 2011. Number of patients initially planned: 94 randomized and 74 completers Final number of patients: 80 randomized and 53 completers
Participant milestones
| Measure |
Exenatide BID
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
37
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
16
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
Baseline characteristics by cohort
| Measure |
Exenatide BID
n=43 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=37 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 monthsPopulation: Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Percentage change in abdominal visceral fat
Outcome measures
| Measure |
Exenatide BID
n=29 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=27 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
|
-5.28 % change
Standard Error 3.23
|
-4.30 % change
Standard Error 3.53
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Percentage change in total abdominal fat
Outcome measures
| Measure |
Exenatide BID
n=26 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=25 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Percentage Change in Total Abdominal Fat From Baseline to 6 Months
|
-5.81 % change
Standard Error 2.28
|
-3.74 % change
Standard Error 2.36
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Percentage change in subcutaneous abdominal fat
Outcome measures
| Measure |
Exenatide BID
n=25 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=25 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months
|
-7.27 % change
Standard Error 1.93
|
-3.56 % change
Standard Error 1.97
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analysed.
Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Outcome measures
| Measure |
Exenatide BID
n=42 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=33 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Change in HbA1c From Baseline to 6 Months
|
-0.69 % change
Standard Error 0.12
|
0.19 % change
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received.Analysis done only for patients with measurement at Month 6.
Percentage of patients with HbA1c values \<= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Outcome measures
| Measure |
Exenatide BID
n=28 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=28 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Percentage of Patients With HbA1c <=7.0% at 6 Months
|
60.7 Percentage of patients
|
21.4 Percentage of patients
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Analysis done only for patients with measurement at Month 6.
Change in Fasting plasma glucose
Outcome measures
| Measure |
Exenatide BID
n=26 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=26 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline to 6 Months
|
-1.47 mmol/L
Standard Error 0.36
|
-0.08 mmol/L
Standard Error 0.38
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analyzed.
Change in weight
Outcome measures
| Measure |
Exenatide BID
n=42 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=33 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Change in Weight From Baseline to 6 Months
|
-2.54 kg
Standard Error 0.57
|
-0.33 kg
Standard Error 0.72
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.
Change in Systolic blood pressure
Outcome measures
| Measure |
Exenatide BID
n=29 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=28 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to 6 Months
|
-7.48 mmHg
Standard Deviation 12.57
|
1.79 mmHg
Standard Deviation 12.41
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.
Change in Diastolic blood pressure
Outcome measures
| Measure |
Exenatide BID
n=29 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=28 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to 6 Months
|
-2.86 mmHg
Standard Deviation 6.99
|
-0.18 mmHg
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Change in total cholesterol
Outcome measures
| Measure |
Exenatide BID
n=29 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=27 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Change in Total Cholesterol From Baseline to 6 Months
|
-0.06 mmol/L
Standard Error 0.18
|
0.14 mmol/L
Standard Error 0.20
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Change in triglycerides
Outcome measures
| Measure |
Exenatide BID
n=29 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=27 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Change in Triglycerides From Baseline to 6 Months
|
-0.17 mmol/L
Standard Error 0.21
|
0.06 mmol/L
Standard Error 0.23
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received
Change in HDL cholesterol
Outcome measures
| Measure |
Exenatide BID
n=29 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=27 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months
|
0.06 mmol/L
Standard Error 0.04
|
0.04 mmol/L
Standard Error 0.04
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.
All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration \< 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value \< 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).
Outcome measures
| Measure |
Exenatide BID
n=43 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
|
Placebo
n=37 Participants
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event
|
0.41 hypoglycemia rate/year
Standard Error 0.15
|
0.12 hypoglycemia rate/year
Standard Error 0.09
|
Adverse Events
Exenatide BID
Placebo
Serious adverse events
| Measure |
Exenatide BID
n=43 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 remainder of 6 months)
|
Placebo
n=37 participants at risk
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/43
|
2.7%
1/37
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/43
|
2.7%
1/37
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/43
|
2.7%
1/37
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.3%
1/43
|
0.00%
0/37
|
|
Gastrointestinal disorders
Mesenteritis
|
2.3%
1/43
|
0.00%
0/37
|
|
General disorders
Malaise
|
0.00%
0/43
|
2.7%
1/37
|
|
Infections and infestations
Diverticulitis
|
2.3%
1/43
|
0.00%
0/37
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.3%
1/43
|
0.00%
0/37
|
Other adverse events
| Measure |
Exenatide BID
n=43 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 remainder of 6 months)
|
Placebo
n=37 participants at risk
Subcutaneous injection of placebo twice a day for 6 months
|
|---|---|---|
|
Ear and labyrinth disorders
vertigo
|
7.0%
3/43
|
0.00%
0/37
|
|
Gastrointestinal disorders
Nausea
|
34.9%
15/43
|
29.7%
11/37
|
|
Gastrointestinal disorders
Diarrhoea
|
16.3%
7/43
|
2.7%
1/37
|
|
Gastrointestinal disorders
Vomiting
|
16.3%
7/43
|
8.1%
3/37
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.3%
4/43
|
2.7%
1/37
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
2/43
|
16.2%
6/37
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
1/43
|
5.4%
2/37
|
|
General disorders
Fatigue
|
11.6%
5/43
|
2.7%
1/37
|
|
General disorders
Injection site reaction
|
4.7%
2/43
|
5.4%
2/37
|
|
Infections and infestations
Nasopharyngitis
|
18.6%
8/43
|
18.9%
7/37
|
|
Infections and infestations
Influenza
|
7.0%
3/43
|
5.4%
2/37
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.6%
8/43
|
10.8%
4/37
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/43
|
5.4%
2/37
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43
|
5.4%
2/37
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
3/43
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43
|
8.1%
3/37
|
|
Nervous system disorders
Headache
|
14.0%
6/43
|
13.5%
5/37
|
|
Nervous system disorders
Dizziness
|
4.7%
2/43
|
8.1%
3/37
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/43
|
5.4%
2/37
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.3%
1/43
|
5.4%
2/37
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place