parallel randomized trial
NCT00603239
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide 10 ug subcutaneous twice daily Exenatide twice daily | thiazolidinedione with or without metformin; lifestyle: not reported | 111 | 110 | |
| A2 | Placebo Placebo | thiazolidinedione with or without metformin; lifestyle: not reported | 54 | 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 |
|---|---|---|---|
| age: >=65 | n | 14 | 7 |
| age | mean (years) | 54.93 | 54.12 |
| age | sd (years) | 8.27 | 9.36 |
| female | n | 44 | 23 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); 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
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 |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -0.84 percent | 0.20 | 110 | not stated; modified itt; registry:outcomes | |
| 26 | A2 | change | -0.10 percent | 0.23 | 54 | not stated; modified itt; registry:outcomes |
Body weight change in kilograms (diabetes) (2 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.43 kg | 0.61 | 111 | not stated; modified itt; registry:outcomes | |
| 26 | A2 | change | -0.75 kg | 0.70 | 54 | not stated; modified itt; registry:outcomes |
HbA1c below 7 percent (2 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 49.0 | 104 | not stated; modified itt; registry:outcomes | ||
| 26 | A2 | responders | 36.5 | 52 | not stated; modified itt; registry:outcomes |
Physical functioning (any instrument) (2 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -3.84 points | 3.06 | 108 | not stated; modified itt; registry:outcomes | |
| 26 | A2 | change | -1.05 points | 3.43 | 53 | not stated; modified itt; registry:outcomes |
Health related quality of life total score (any instrument) (2 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.56 points | 2.21 | 108 | not stated; modified itt; registry:outcomes | |
| 26 | A2 | change | 0.11 points | 2.49 | 53 | not stated; modified itt; registry:outcomes |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 111 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 54 | 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 / 111 | not stated; randomized; registry:flow | ||||
| A2 | events | 1 / 54 | not stated; randomized; registry:flow |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13 / 111 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 54 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 111 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 54 | not stated; safety; registry:adverse_events |