parallel randomized trial
S002888
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | liraglutide Liraglutide plus metformin | metformin 1500 mg daily; 500 kcal deficit diet and 150 min weekly exercise advice; lifestyle: standard | 50 | 50 | |
| A2 | Standard care or no added treatment Metformin alone (control) | metformin 1500 mg daily; 500 kcal deficit diet and 150 min weekly exercise advice; lifestyle: standard | 50 | 50 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide plus metformin A1 | Standard care or no added treatment A2 |
|---|---|---|---|
| age | mean (years) | 34.80 | 35.78 |
| age | sd (years) | 9.60 | 12.89 |
| bmi | mean (kg/m2) | 36.34 | 34.67 |
| bmi | sd (kg/m2) | 3.57 | 4.29 |
| female | n | 30 | 27 |
| hba1c | median (percent) | 6.15 | 5.60 |
| hba1c | q1 (percent) | 5.68 | 5.20 |
| hba1c | q3 (percent) | 6.90 | 6.09 |
| sbp | mean (mmHg) | 141.38 | 139.26 |
| sbp | sd (mmHg) | 16.39 | 14.88 |
| weight | mean (kg) | 104.41 | 98.68 |
| weight | sd (kg) | 15.34 | 17.02 |
Results
4 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent body weight change (2 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | percent change | -14.45 percent | 50 | not stated; randomized; R0003281:Results | ||
| 24 | A2 | percent change | -11.32 percent | 50 | not stated; randomized; R0003281:Results |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 50 | not stated; randomized; R0003281:Methods | ||||
| A2 | events | 0 / 50 | not stated; randomized; R0003281:Methods |