crossover randomized trial
S003021
Other conditionsS003021
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo single dose | lifestyle: not reported | 20 | ||
| A2 | lixisenatide Lixisenatide 2.5 ug single dose | lifestyle: not reported | 20 | ||
| A3 | lixisenatide Lixisenatide 5 ug single dose | lifestyle: not reported | 20 | ||
| A4 | lixisenatide Lixisenatide 10 ug single dose | lifestyle: not reported | 20 | ||
| A5 | lixisenatide Lixisenatide 20 ug single dose | lifestyle: not reported | 20 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Lixisenatide 2.5 ug single dose A2 | Lixisenatide 5 ug single dose A3 | Lixisenatide 10 ug single dose A4 | Lixisenatide 20 ug single dose A5 | Whole trial ALL |
|---|---|---|---|---|---|---|---|
| age | max (years) | 44 | |||||
| age | mean (years) | 31.0 | |||||
| age | min (years) | 18 | |||||
| age | sd (years) | 7.3 | |||||
| asian | n | 1 | |||||
| asian | percent | 5.0 | |||||
| bmi | mean (kg/m2) | 22.8 | |||||
| bmi | sd (kg/m2) | 2.7 | |||||
| female | n | 10 | |||||
| female | percent | 50.0 | |||||
| weight | mean (kg) | 69.7 | |||||
| weight | sd (kg) | 14.6 | |||||
| white | n | 19 | |||||
| white | percent | 95.0 |
Results
20 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Serious adverse events (5 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A2 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A3 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A4 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A5 | events | 0 / 20 | not stated; safety; R0015417:Results |
Discontinuation due to adverse events (5 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A2 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A3 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A4 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A5 | events | 0 / 20 | not stated; safety; R0015417:Results |
Discontinuation due to gastrointestinal adverse events (5 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A2 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A3 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A4 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A5 | events | 0 / 20 | not stated; safety; R0015417:Results |
Death by suicide (5 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A2 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A3 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A4 | events | 0 / 20 | not stated; safety; R0015417:Results | ||||
| A5 | events | 0 / 20 | not stated; safety; R0015417:Results |