parallel randomized trial
S003016
Type 2 diabetes (adults)S003016
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Dapagliflozin Dapagliflozin plus metformin | metformin at least 1500 mg daily; lifestyle: not reported | 12 | 12 | |
| A2 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide plus metformin | metformin at least 1500 mg daily; lifestyle: not reported | 12 | 12 | |
| A3 | Acarbose Acarbose plus metformin | metformin at least 1500 mg daily; lifestyle: not reported | 12 | 12 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Dapagliflozin A1 | Liraglutide 1.8 mg subcutaneous once daily A2 | Acarbose A3 |
|---|---|---|---|---|
| age | mean (years) | 57.0 | 51.9 | 56.4 |
| age | sd (years) | 9.5 | 10.2 | 8.9 |
| bmi | mean (kg/m2) | 26.7 | 27.3 | 27.2 |
| bmi | sd (kg/m2) | 1.2 | 1.6 | 1.9 |
| diabetes duration | mean (years) | 8.5 | 7.8 | 6.6 |
| diabetes duration | sd (years) | 8.4 | 5.0 | 4.4 |
| female | n | 7 | 6 | 5 |
| female | percent | 58.3 | 50.0 | 41.7 |
| hba1c | mean (percent) | 8.2 | 8.5 | 7.9 |
| hba1c | sd (percent) | 1.0 | 1.0 | 0.9 |
| sbp | mean (mmHg) | 135.9 | 136.2 | 134.8 |
| sbp | sd (mmHg) | 7.8 | 14.5 | 15.2 |
| waist | mean (cm) | 97.3 | 94.8 | 93.0 |
| waist | sd (cm) | 5.4 | 6.8 | 7.6 |
| weight | mean (kg) | 74.6 | 73.7 | 73.4 |
| weight | sd (kg) | 8.1 | 8.6 | 6.8 |
Results
9 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (3 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 16 | A1 | final | 7.0 percent | 1.2 | 12 | not stated; randomized; R0016968:Table 1 | |
| 16 | A2 | final | 7.1 percent | 0.7 | 12 | not stated; randomized; R0016968:Table 1 | |
| 16 | A3 | final | 7.1 percent | 0.7 | 12 | not stated; randomized; R0016968:Table 1 |
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 16 | A1 | final | 71.8 kg | 7.8 | 12 | not stated; randomized; R0016968:Table 1 | |
| 16 | A2 | final | 71.3 kg | 9.1 | 12 | not stated; randomized; R0016968:Table 1 | |
| 16 | A3 | final | 71.7 kg | 5.9 | 12 | not stated; randomized; R0016968:Table 1 |
Systolic blood pressure change (3 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 16 | A1 | final | 132.8 mmHg | 7.2 | 12 | not stated; randomized; R0016968:Table 1 | |
| 16 | A2 | final | 136.7 mmHg | 11.6 | 12 | not stated; randomized; R0016968:Table 1 | |
| 16 | A3 | final | 130.1 mmHg | 14.9 | 12 | not stated; randomized; R0016968:Table 1 |