parallel randomized trial
NCT00375492
Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide 10 ug subcutaneous twice daily Exenatide twice daily | lifestyle: not reported | 96 | 70 | |
| A2 | Placebo Placebo | lifestyle: not reported | 98 | 72 |
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: 65 or older | n | 18 | 16 | |
| age | mean (years) | 54.52 | 55.08 | 54.81 |
| age | sd (years) | 10.02 | 8.97 | 9.48 |
| female | n | 60 | 61 | 121 |
| hba1c | mean (percent) | 7.74 | 7.51 | 7.62 |
| hba1c | sd (percent) | 0.87 | 0.82 | 0.85 |
| waist | mean (cm) | 109.64 | 108.85 | 109.24 |
| waist | sd (cm) | 11.12 | 12.10 | 11.60 |
| weight | mean (kg) | 94.90 | 96.16 | 95.53 |
| weight | sd (kg) | 16.52 | 16.53 | 16.05 |
Analyses this trial contributes to
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
18 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (2 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -1.21 percent | 0.09 | 70 | not stated; randomized; registry:outcomes | |
| 24 | A2 | change | -0.73 percent | 0.09 | 71 | not stated; randomized; registry:outcomes |
Body weight change in kilograms (diabetes) (2 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -6.16 kg | 0.54 | 70 | not stated; randomized; registry:outcomes | |
| 24 | A2 | change | -3.97 kg | 0.52 | 72 | not stated; randomized; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 33 / 96 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 30 / 98 | not stated; randomized; registry:outcomes |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 96 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 98 | 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 | 4 / 96 | not stated; randomized; registry:flow | ||||
| A2 | events | 5 / 98 | not stated; randomized; registry:flow |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 43 / 96 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 19 / 98 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 21 / 96 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 9 / 98 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 18 / 96 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 21 / 98 | not stated; safety; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 96 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 10 / 98 | not stated; safety; registry:adverse_events |