parallel randomized trial
S003055
Type 2 diabetes (adults)S003055
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | liraglutide and dapagliflozin Intervention arm (liraglutide, dapagliflozin, metformin) | metformin up to 2000 mg/day; lifestyle: standard | 14 | ||
| A2 | Vildagliptin glimepiride Vildagliptin, glimepiride and metformin (control) | metformin at maximum tolerated dose; lifestyle: standard | 15 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Intervention arm (liraglutide, dapagliflozin, metformin) A1 | Vildagliptin glimepiride A2 |
|---|---|---|---|
| age | median (years) | 51 | 40 |
| age | q1 (years) | 40 | 37 |
| age | q3 (years) | 58 | 51 |
| bmi | mean (kg/m2) | 29.20 | 29.18 |
| bmi | median (kg/m2) | 28.5 | 26.78 |
| bmi | q1 (kg/m2) | 25.6 | 25.46 |
| bmi | q3 (kg/m2) | 32.4 | 32.05 |
| bmi | sd (kg/m2) | 4.74 | 6.13 |
| diabetes duration | mean (months) | 20.5 | 18.67 |
| diabetes duration | median (months) | 18 | 14 |
| diabetes duration | q1 (months) | 9.5 | 10 |
| diabetes duration | q3 (months) | 32.75 | 29 |
| diabetes duration | sd (months) | 12.45 | 13.31 |
| female | n | 8 | 5 |
| female | percent | 61.5 | 38.5 |
| hba1c | mean (percent) | 6.39 | 6.75 |
| hba1c | median (percent) | 6.35 | 6.5 |
| hba1c | q1 (percent) | 6.20 | 6.1 |
| hba1c | q3 (percent) | 6.63 | 7.4 |
| hba1c | sd (percent) | 0.39 | 0.79 |
| weight | mean (kg) | 76.85 | 78.72 |
| weight | median (kg) | 75 | 81.6 |
| weight | q1 (kg) | 68 | 64.4 |
| weight | q3 (kg) | 82.95 | 85.5 |
| weight | sd (kg) | 17.14 | 14.75 |
Results
12 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (2 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | final | 5.96 percent | 0.35 | not stated; other; R0023818:Table 3 | ||
| 12 | A2 | final | 5.95 percent | 0.39 | not stated; other; R0023818:Table 3 |
Body weight change in kilograms (diabetes) (2 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | change | kg | not stated; other; R0023818:Table 3 | |||
| 12 | A2 | change | kg | not stated; other; R0023818:Table 3 |
Level 2 or 3 hypoglycemia (participants) (5 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / | not stated; other; R0023818:Results | ||||
| A1 | events | 0 / | not stated; other; R0023818:Results | ||||
| A1 | events | 0 / | not stated; other; R0023818:Results | ||||
| A2 | events | 2 / | not stated; other; R0023818:Results | ||||
| A2 | events | 1 / | not stated; other; R0023818:Results |
Discontinuation due to adverse events (1 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 1 / | not stated; other; R0023818:Results |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 72.73 | not stated; other; gastrointestinal symptoms; R0023818:Results | ||||
| A2 | events | 15.39 | not stated; other; gastrointestinal symptoms; R0023818:Results |