parallel randomized trial
NCT00500370
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug BID | none; lifestyle: intensive | 80 | 73 | 48 |
| A2 | Placebo Placebo | structured diet and physical activity program; lifestyle: intensive | 83 | 79 | 54 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Exenatide 10 ug subcutaneous twice daily A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 47.01 | 45.15 | |
| age | sd (years) | 10.95 | 12.74 | |
| bmi | mean (kg/m2) | 39.64 | 39.39 | |
| female | n | 58 | 67 | |
| hba1c | mean (percent) | 5.61 | 5.58 | |
| other igt or ifg | n | 38 | ||
| other igt or ifg | percent | 25 | ||
| weight | mean (kg) | 109.5 | 107.6 |
Analyses this trial contributes to
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- VomitingOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- VomitingOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
Results
18 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent body weight change (1 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 vs A2 | md | -3.3 percent | 0.5 | not stated; modified itt; R0026955:Results |
Weight loss of 5 percent or more (2 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 31.5 | 73 | not stated; modified itt; registry:outcomes | ||
| 24 | A2 | responders | 16.5 | 79 | not stated; modified itt; registry:outcomes |
Progression to type 2 diabetes (2 lines; O14)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 65 | not stated; modified itt; registry:outcomes | ||||
| A2 | events | 2 / 65 | not stated; modified itt; registry:outcomes |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 73 | not stated; modified itt; R0026955:Results | ||||
| A2 | events | 0 / 79 | not stated; modified itt; R0026955:Results |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 73 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 79 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 80 | not stated; randomized; registry:flow | ||||
| A2 | events | 3 / 83 | not stated; randomized; registry:flow |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 18 / 73 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 79 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 73 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 79 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 10 / 73 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 79 | not stated; safety; registry:adverse_events |
Discontinuation due to gastrointestinal adverse events (1 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 80 | not stated; randomized; R0026955:Results |