parallel randomized trial
NCT00135330
An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug BID | metformin; lifestyle: not reported | 45 | 45 | |
| A2 | Exenatide and rosiglitazone 10 to 4 µg injection twice daily Exenatide 10 ug BID plus rosiglitazone 4 mg BID | metformin; lifestyle: not reported | 47 | 47 | |
| A3 | Rosiglitazone Rosiglitazone 4 mg BID | metformin; lifestyle: not reported | 45 | 45 |
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 | Exenatide and rosiglitazone 10 to 4 µg injection twice daily A2 | Rosiglitazone A3 | Whole trial ALL |
|---|---|---|---|---|---|
| age | mean (years) | 56.99 | 54.63 | 55.54 | |
| age | sd (years) | 9.71 | 9.91 | 10.71 | |
| black | n | 16 | |||
| black | percent | 12 | |||
| bmi | mean (kg/m2) | 32.5 | |||
| bmi | sd (kg/m2) | 4.3 | |||
| diabetes duration | mean (years) | 4.7 | |||
| diabetes duration | sd (years) | 3.7 | |||
| female | n | 22 | 25 | 20 | |
| hba1c | mean (percent) | 7.8 | 7.8 | 7.9 | |
| hba1c | se (percent) | 0.1 | 0.1 | 0.1 | |
| hispanic | n | 32 | |||
| hispanic | percent | 23 | |||
| other race other | n | 5 | |||
| other race other | percent | 4 | |||
| waist | mean (cm) | 105.98 | 106.85 | 105.34 | |
| waist | se (cm) | 1.68 | 1.67 | 1.67 | |
| weight | mean (kg) | 93.0 | 93.8 | 91.8 | |
| weight | se (kg) | 2.4 | 2.4 | 2.4 | |
| white | n | 84 | |||
| white | percent | 61 |
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
- 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
55 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (6 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 20 | A1 | change | -0.908 percent | 0.118 | 35 | not stated; modified itt; registry:outcomes | |
| 20 | A1 | change | -0.9 percent | 0.1 | 45 | not stated; modified itt; R0027805:Table 1 | |
| 20 | A2 | change | -1.3 percent | 0.1 | 47 | not stated; modified itt; R0027805:Table 1 | |
| 20 | A2 | change | -1.31 percent | 0.116 | 36 | not stated; modified itt; registry:outcomes | |
| 20 | A3 | change | -1.0 percent | 0.1 | 45 | not stated; modified itt; R0027805:Table 1 | |
| 20 | A3 | change | -0.968 percent | 0.118 | 34 | not stated; modified itt; registry:outcomes |
Body weight change in kilograms (diabetes) (6 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 20 | A1 | change | -2.82 kg | 0.547 | 44 | not stated; modified itt; registry:outcomes | |
| 20 | A1 | change | -2.8 kg | 0.5 | 45 | not stated; modified itt; R0027805:Table 1 | |
| 20 | A2 | change | -1.2 kg | 0.5 | 47 | not stated; modified itt; R0027805:Table 1 | |
| 20 | A2 | change | -1.21 kg | 0.538 | 45 | not stated; modified itt; registry:outcomes | |
| 20 | A3 | change | 1.5 kg | 0.5 | 45 | not stated; modified itt; R0027805:Table 1 | |
| 20 | A3 | change | 1.48 kg | 0.547 | 44 | not stated; modified itt; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (7 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / | not stated; other; R0027805:Results | ||||
| A1 | events | 8 / 45 | not stated; full analysis; registry:outcomes | ||||
| A2 | events | 2 / | not stated; other; R0027805:Results | ||||
| A2 | events | 1 / | not stated; other; R0027805:Results | ||||
| A2 | events | 9 / 47 | not stated; full analysis; registry:outcomes | ||||
| A3 | events | 0 / | not stated; other; R0027805:Results | ||||
| A3 | events | 6 / 45 | not stated; full analysis; registry:outcomes |
Acute kidney injury (3 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 45 | not stated; randomized; renal failure acute; registry:adverse_events | ||||
| A2 | events | 0 / 47 | not stated; randomized; renal failure acute; registry:adverse_events | ||||
| A3 | events | 1 / 45 | not stated; randomized; renal failure acute; registry:adverse_events |
Serious adverse events (3 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 45 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 4 / 47 | not stated; randomized; registry:adverse_events | ||||
| A3 | events | 4 / 45 | not stated; randomized; registry:adverse_events |
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 45 | not stated; randomized; registry:flow | ||||
| A2 | events | 5 / 47 | not stated; randomized; registry:flow | ||||
| A3 | events | 1 / 45 | not stated; randomized; registry:flow |
Nausea (6 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 47 | not stated; other; R0027805:Results | ||||
| A1 | events | 21 / 45 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 47 | not stated; other; R0027805:Results | ||||
| A2 | events | 22 / 47 | not stated; randomized; registry:adverse_events | ||||
| A3 | events | 4 | not stated; other; R0027805:Results | ||||
| A3 | events | 2 / 45 | not stated; randomized; registry:adverse_events |
Vomiting (6 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 22 | not stated; other; R0027805:Results | ||||
| A1 | events | 10 / 45 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 19 | not stated; other; R0027805:Results | ||||
| A2 | events | 9 / 47 | not stated; randomized; registry:adverse_events | ||||
| A3 | events | 0 | not stated; other; R0027805:Results | ||||
| A3 | events | 0 / 45 | not stated; randomized; registry:adverse_events |
Diarrhea (6 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 | not stated; other; R0027805:Results | ||||
| A1 | events | 3 / 45 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 21 | not stated; other; R0027805:Results | ||||
| A2 | events | 10 / 47 | not stated; randomized; registry:adverse_events | ||||
| A3 | events | 4 | not stated; other; R0027805:Results | ||||
| A3 | events | 2 / 45 | not stated; randomized; registry:adverse_events |
Constipation (3 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 45 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 3 / 47 | not stated; randomized; registry:adverse_events | ||||
| A3 | events | 0 / 45 | not stated; randomized; registry:adverse_events |
Discontinuation due to gastrointestinal adverse events (3 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / | not stated; other; nausea; R0027805:Results | ||||
| A2 | events | 2 / | not stated; other; nausea; R0027805:Results | ||||
| A2 | events | 1 / | not stated; other; vomiting; R0027805:Results |
Suicidal ideation or behavior (3 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 45 | not stated; randomized; suicidal ideation; registry:adverse_events | ||||
| A2 | events | 1 / 47 | not stated; randomized; suicidal ideation; registry:adverse_events | ||||
| A3 | events | 0 / 45 | not stated; randomized; suicidal ideation; registry:adverse_events |