parallel randomized trial
S003433
Type 2 diabetes (adults)S003433
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | GLP-1 receptor agonist, agent not named GLP-1 receptor agonist plus metformin and basal insulin | metformin and basal insulin; lifestyle: not reported | 61 | ||
| A2 | Sulfonylurea Sulfonylurea added to metformin and basal insulin | metformin and basal insulin; lifestyle: not reported | 40 | ||
| A3 | Basal bolus insulin Basal bolus insulin with metformin | metformin; lifestyle: not reported | 40 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | GLP-1 receptor agonist plus metformin and basal insulin A1 | Sulfonylurea A2 | Basal bolus insulin A3 |
|---|---|---|---|---|
| age | median (years) | 58.0 | 63.0 | 61.0 |
| age | q1 (years) | 53.0 | 57.8 | 57.0 |
| age | q3 (years) | 66.0 | 70.2 | 66.0 |
| bmi | median (kg/m2) | 37.5 | 35.8 | 38.2 |
| bmi | q1 (kg/m2) | 35.0 | 35.0 | 36.0 |
| bmi | q3 (kg/m2) | 42.5 | 38.0 | 43.1 |
| diabetes duration | median (years) | 11.5 | 11.0 | 14.0 |
| diabetes duration | q1 (years) | 10.0 | 6.5 | 10.0 |
| diabetes duration | q3 (years) | 16.2 | 15.0 | 20.0 |
| female | n | 34 | 30 | 34 |
| female | percent | 55.7 | 75.0 | 85.0 |
| hba1c | median (percent) | 9.5 | 8.2 | 9.4 |
| hba1c | q1 (percent) | 8.6 | 7.5 | 8.5 |
| hba1c | q3 (percent) | 10.8 | 9.6 | 10.4 |
| insulin dose | median (U/day) | 30.0 | 16.0 | 85.0 |
| insulin dose | q1 (U/day) | 25.0 | 12.0 | 73.5 |
| insulin dose | q3 (U/day) | 42.0 | 18.5 | 100.5 |
| weight | median (kg) | 108.0 | 98.0 | 107.5 |
| weight | q1 (kg) | 99.0 | 92.2 | 96.5 |
| weight | q3 (kg) | 120.0 | 110.2 | 118.0 |
Results
17 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (6 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | percent | -2.10 to -1.10 | not stated; other; R0052046:Table 2 | ||
| 24 | A1 | final | percent | not stated; other; R0052046:Table 2 | |||
| 24 | A2 | change | percent | -0.90 to -0.25 | not stated; other; R0052046:Table 2 | ||
| 24 | A2 | final | percent | not stated; other; R0052046:Table 2 | |||
| 24 | A3 | change | percent | -1.60 to -0.85 | not stated; other; R0052046:Table 2 | ||
| 24 | A3 | final | percent | not stated; other; R0052046:Table 2 |
Body weight change in kilograms (diabetes) (6 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | kg | -9.0 to -4.0 | not stated; other; R0052046:Table 5 | ||
| 24 | A1 | final | kg | not stated; other; R0052046:Table 5 | |||
| 24 | A2 | change | kg | 0.0 to 1.0 | not stated; other; R0052046:Table 5 | ||
| 24 | A2 | final | kg | not stated; other; R0052046:Table 5 | |||
| 24 | A3 | final | kg | not stated; other; R0052046:Table 5 | |||
| 24 | A3 | change | kg | -6.0 to 10.0 | not stated; other; R0052046:Table 5 |
Level 2 or 3 hypoglycemia (participants) (3 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / | not stated; other; R0052046:Results | ||||
| A1 | events | 0 / | not stated; other; R0052046:Results | ||||
| A3 | events | 1 / | not stated; other; R0052046:Results |
Discontinuation due to adverse events (1 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 61 | not stated; randomized; R0052046:Results |
Discontinuation due to gastrointestinal adverse events (1 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 61 | not stated; randomized; R0052046:Results |