parallel randomized trial
S003061
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Lifestyle intervention (randomized arm) Lifestyle intervention | metformin at highest tolerated dose; lifestyle: intensive | 31 | 15 | 15 |
| A2 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide | metformin at highest tolerated dose; lifestyle: standard | 31 | 17 | 17 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Lifestyle intervention (randomized arm) A1 | Liraglutide 1.8 mg subcutaneous once daily A2 |
|---|---|---|---|
| age | median (years) | 53.00 | 55.00 |
| age | q1 (years) | 51.00 | 48.50 |
| age | q3 (years) | 55.00 | 63.50 |
| bmi | median (kg/m2) | 35.35 | 38.86 |
| bmi | q1 (kg/m2) | 30.90 | 34.26 |
| bmi | q3 (kg/m2) | 40.52 | 42.31 |
| established cvd | n | 2 | 1 |
| established cvd | percent | 13.3 | 5.9 |
| hba1c | median (mmol/mol) | 43 | 42 |
| hba1c | q1 (mmol/mol) | 37 | 38 |
| hba1c | q3 (mmol/mol) | 50 | 52 |
| metformin use | n | 15 | 17 |
| metformin use | percent | 100 | 100 |
| other male | n | 8 | 9 |
| other male | percent | 53.3 | 52.9 |
| sbp | median (mmHg) | 131.00 | 144.00 |
| sbp | q1 (mmHg) | 123.00 | 129.00 |
| sbp | q3 (mmHg) | 146.00 | 152.00 |
| waist | median (cm) | 116.0 | 118.0 |
| waist | q1 (cm) | 110.0 | 112.0 |
| waist | q3 (cm) | 132.0 | 129.0 |
| weight | median (kg) | 96.10 | 109.00 |
| weight | q1 (kg) | 88.60 | 97.55 |
| weight | q3 (kg) | 124.00 | 116.35 |
Results
8 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 |
|---|---|---|---|---|---|---|---|
| 17.38 | A1 | final | mmol/mol | 15 | not stated; completers; R0022119:Table 3 | ||
| 17.38 | A2 | final | mmol/mol | 17 | not stated; completers; R0022119:Table 3 |
Body weight change in kilograms (diabetes) (2 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 17.38 | A1 | final | kg | 15 | not stated; completers; R0022119:Table 3 | ||
| 17.38 | A2 | final | kg | 17 | not stated; completers; R0022119:Table 3 |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 31 | not stated; randomized; R0022119:Figure 1 | ||||
| A2 | events | 1 / 31 | not stated; randomized; severe anemia; R0022119:Figure 1 |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 31 | not stated; randomized; R0022119:Figure 1 | ||||
| A2 | events | 0 / 31 | not stated; randomized; R0022119:Figure 1 |