parallel randomized trial
S002991
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide flexible dose injection once weekly Semaglutide plus insulin (observation group) | insulin aspart once daily before evening meal; lifestyle: standard | 110 | 110 | |
| A2 | Insulin aspart (prandial) Conventional insulin (control group) | lifestyle: standard | 110 | 110 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide flexible dose injection once weekly A1 | Insulin aspart (prandial) A2 |
|---|---|---|---|
| age | mean (years) | 68.69 | 68.71 |
| age | sd (years) | 3.92 | 3.95 |
| bmi | mean (kg/m2) | 21.52 | 21.50 |
| bmi | sd (kg/m2) | 1.57 | 1.55 |
| egfr | mean (mL/min/1.73 m2) | 67.52 | 68.47 |
| egfr | sd (mL/min/1.73 m2) | 6.78 | 6.81 |
| female | n | 54 | 45 |
| female | percent | 49.09 | 40.91 |
| hba1c | mean (percent) | 10.29 | 10.31 |
| hba1c | sd (percent) | 2.78 | 2.79 |
| insulin dose | mean (U/day) | 30.0 | 29.8 |
| insulin dose | sd (U/day) | 4.2 | 4.1 |
| uacr | mean (mg/L) | 61.58 | 62.36 |
| uacr | sd (mg/L) | 6.84 | 6.87 |
| weight | mean (kg) | 65.4 | 64.9 |
| weight | sd (kg) | 8.2 | 8.0 |
Analyses this trial contributes to
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; descriptive only
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaChronic kidney disease with diabetes; longest follow-up; descriptive only
- NauseaChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationChronic kidney disease with diabetes; longest follow-up; descriptive only
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationChronic kidney disease with diabetes; longest follow-up; descriptive only
- ConstipationType 2 diabetes (adults); longest follow-up; descriptive only
Results
11 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 |
|---|---|---|---|---|---|---|---|
| 13.04 | A1 | final | 6.63 percent | 1.25 | 110 | not stated; randomized; R0009861:Table 2 | |
| 13.04 | A2 | final | 7.84 percent | 1.61 | 110 | not stated; randomized; R0009861:Table 2 |
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 13.04 | A1 | change | -4.2 kg | 1.3 | not stated; other; R0009861:Results | ||
| 13.04 | A1 | final | 61.2 kg | 7.5 | not stated; other; R0009861:Results | ||
| 13.04 | A2 | final | 64.8 kg | 7.9 | not stated; other; R0009861:Results |
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 110 | not stated; other; R0009861:Results | ||||
| A2 | events | 5 / 110 | not stated; other; R0009861:Results |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 110 | not stated; other; R0009861:Results | ||||
| A2 | events | 1 / 110 | not stated; other; R0009861:Results |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 110 | not stated; other; R0009861:Results | ||||
| A2 | events | 1 / 110 | not stated; other; R0009861:Results |