crossover randomized trial
NCT00729326
Comparison of the Effect of Exenatide vs. Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily | metformin or TZD; placebo capsule daily; lifestyle: not reported | 86 | 67 | |
| A2 | Sitagliptin Sitagliptin 100 mg daily | metformin or TZD; placebo injections twice daily; lifestyle: not reported | 86 | 66 |
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 | Sitagliptin A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 54 | ||
| age | sd (years) | 10 | ||
| black | n | 5 | ||
| black | percent | 6 | ||
| bmi | mean (kg/m2) | 34.9 | ||
| bmi | sd (kg/m2) | 5.5 | ||
| diabetes duration | mean (years) | 7 | ||
| diabetes duration | sd (years) | 7 | ||
| female | n | 48 | ||
| female | percent | 58 | ||
| hba1c | mean (percent) | 8.3 | ||
| hba1c | sd (percent) | 1.0 | ||
| hispanic | n | 55 | ||
| hispanic | percent | 66 | ||
| metformin use | n | 82 | ||
| other race american indian alaska native | n | 1 | ||
| other race american indian alaska native | percent | 1 | ||
| sbp | mean (mmHg) | 124.6 | 125.4 | |
| sbp | se (mmHg) | 1.8 | 1.8 | |
| weight | mean (kg) | 96.1 | ||
| weight | sd (kg) | 21.4 | ||
| white | n | 77 | ||
| white | percent | 93 |
Results
32 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 4 | A1 | change | -1.37 kg | not stated; modified itt; R0026752:Results | |||
| 4 | A1 vs A2 | md | -0.48 kg | not stated; modified itt; R0026752:Results | |||
| 4 | A2 | change | -0.89 kg | not stated; modified itt; R0026752:Results |
Level 2 or 3 hypoglycemia (participants) (6 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 73 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 3 / 70 | not stated; full analysis; R0026752:Results | ||||
| A1 | events | 2.9 | 35 | not stated; full analysis; registry:outcomes | |||
| A2 | events | 2 / 73 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 71 | not stated; full analysis; R0026752:Results | ||||
| A2 | events | 2.7 | 37 | not stated; full analysis; registry:outcomes |
Systolic blood pressure change (2 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 4 | A1 | change | -2.5 mmHg | 1.5 | -5.6 to 0.5 | not stated; modified itt; R0026752:Table 2 | |
| 4 | A2 | change | -2.0 mmHg | 1.6 | -5.1 to 1.1 | not stated; modified itt; R0026752:Table 2 |
All cause mortality (1 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 0 / 73 | not stated; safety; R0026752:Results |
Hospitalization for heart failure (1 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 0 / 73 | not stated; safety; R0026752:Results |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 73 | not stated; safety; R0026752:Results | ||||
| A2 | events | 0 / 73 | not stated; safety; R0026752:Results |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 86 | not stated; randomized; R0026752:Results | ||||
| A2 | events | 0 / 86 | not stated; randomized; R0026752:Results |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 39 | not stated; randomized; R0026752:Results | ||||
| A1 | events | 27 / 73 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 15 | not stated; randomized; R0026752:Results | ||||
| A2 | events | 12 / 73 | not stated; safety; registry:adverse_events |
Vomiting (4 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 19 | not stated; randomized; R0026752:Results | ||||
| A1 | events | 15 / 73 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 5 | not stated; randomized; R0026752:Results | ||||
| A2 | events | 4 / 73 | not stated; safety; registry:adverse_events |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 10 | not stated; randomized; R0026752:Results | ||||
| A1 | events | 7 / 73 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 10 | not stated; randomized; R0026752:Results | ||||
| A2 | events | 8 / 73 | not stated; safety; registry:adverse_events |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 86 | not stated; randomized; R0026752:Results | ||||
| A2 | events | 0 / 86 | not stated; randomized; R0026752:Results |
Death by suicide (1 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 0 / 73 | not stated; safety; R0026752:Results |