parallel randomized trial
S003130
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Standard care or no added treatment Control group | metformin 500 mg twice daily; lifestyle: not reported | 66 | 63 | |
| A2 | Insulin Insulin group | metformin 500 mg twice daily; lifestyle: not reported | 71 | 71 | |
| A3 | GLP-1 receptor agonist (agent not reported) GLP-1 receptor agonist group | metformin 500 mg twice daily; lifestyle: not reported | 62 | 57 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Standard care or no added treatment A1 | Insulin A2 | GLP-1 receptor agonist group A3 |
|---|---|---|---|---|
| age | mean (years) | 60.13 | 52.75 | |
| age | median (years) | 61.00 | ||
| age | q1 (years) | 50.75 | ||
| age | q3 (years) | 71.00 | ||
| age | sd (years) | 10.24 | 15.24 | |
| bmi | mean (kg/m2) | 25.82 | ||
| bmi | median (kg/m2) | 26.53 | 27.18 | |
| bmi | q1 (kg/m2) | 24.37 | 25.00 | |
| bmi | q3 (kg/m2) | 30.07 | 29.83 | |
| bmi | sd (kg/m2) | 3.14 | ||
| diabetes duration | median (years) | 10.00 | 10.00 | 7.50 |
| diabetes duration | q1 (years) | 6.00 | 3.00 | 4.00 |
| diabetes duration | q3 (years) | 20.00 | 17.00 | 12.75 |
| egfr | mean (mL/min/1.73 m2) | 91.52 | 91.03 | |
| egfr | median (mL/min/1.73 m2) | 100.92 | ||
| egfr | q1 (mL/min/1.73 m2) | 94.32 | ||
| egfr | q3 (mL/min/1.73 m2) | 115.56 | ||
| egfr | sd (mL/min/1.73 m2) | 18.81 | 21.74 | |
| hba1c | mean (percent) | 8.39 | ||
| hba1c | median (percent) | 7.75 | 9.35 | |
| hba1c | q1 (percent) | 6.98 | 8.00 | |
| hba1c | q3 (percent) | 8.70 | 11.05 | |
| hba1c | sd (percent) | 1.44 | ||
| other male | percent | 63.5 | 49.3 | 31.6 |
| uacr | median (mg/g) | 38.95 | 39.15 | 39.44 |
| uacr | q1 (mg/g) | 33.22 | 35.06 | 35.52 |
| uacr | q3 (mg/g) | 76.89 | 53.62 | 48.50 |
| weight | mean (kg) | 72.93 | ||
| weight | median (kg) | 73.50 | 76.50 | |
| weight | q1 (kg) | 66.75 | 65.00 | |
| weight | q3 (kg) | 85.00 | 87.00 | |
| weight | sd (kg) | 11.60 |
Results
3 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 |
|---|---|---|---|---|---|---|---|
| 12 | A1 | final | 6.74 percent | 0.97 | 63 | not stated; completers; R0004335:Table 2A | |
| 12 | A2 | final | 7.16 percent | 1.05 | 71 | not stated; completers; R0004335:Table 2A | |
| 12 | A3 | final | 6.72 percent | 0.90 | 57 | not stated; completers; R0004335:Table 2A |