parallel randomized trial
S003091
Other conditionsS003091
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Insulin Group 1A insulin alone (CBG 181 to 240) | lifestyle: not reported | 30 | 30 | |
| A2 | Liraglutide 1.2 mg subcutaneous once daily Group 1B liraglutide alone (CBG 181 to 240) | lifestyle: not reported | 30 | 30 | |
| A3 | Standard care or no added treatment Group 2A insulin alone (CBG 241 to 300) | insulin; lifestyle: not reported | 30 | 30 | |
| A4 | Liraglutide 1.2 mg subcutaneous once daily Group 2B insulin plus liraglutide (CBG 241 to 300) | insulin; lifestyle: not reported | 30 | 30 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Insulin A1 | Liraglutide 1.2 mg subcutaneous once daily A2 | Standard care or no added treatment A3 | Liraglutide 1.2 mg subcutaneous once daily A4 |
|---|---|---|---|---|---|
| age | mean (years) | 55.1 | 58.9 | 55.5 | 58.8 |
| age | sd (years) | 13.1 | 12.7 | 17.1 | 12.5 |
| bmi | mean (kg/m2) | 31.5 | 30.8 | 28.9 | 31.1 |
| bmi | sd (kg/m2) | 6.7 | 6.4 | 6.9 | 7.9 |
| female | n | 6 | 8 | 6 | 7 |
| hba1c | mean (percent) | 6.8 | 6.8 | 7 | 7.6 |
| hba1c | sd (percent) | 1.4 | 1.5 | 1.5 | 1.7 |
| weight | mean (kg) | 87.8 | 86.7 | 80 | 86.1 |
| weight | sd (kg) | 17.1 | 16.5 | 17.5 | 19.6 |
Results
4 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 30 | not stated; randomized; nausea/vomiting; R0025770:Table 2 | ||||
| A2 | events | 9 / 30 | not stated; randomized; nausea/vomiting; R0025770:Table 2 | ||||
| A3 | events | 3 / 30 | not stated; randomized; nausea/vomiting; R0025770:Table 2 | ||||
| A4 | events | 10 / 30 | not stated; randomized; nausea/vomiting; R0025770:Table 2 |