parallel randomized trial
SEMA-VR
Semaglutide and Vascular Regeneration in People With Diabetes and/or Obesity
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Standard care or no added treatment Usual care | lifestyle: not reported | 37 | 24 | |
| A2 | Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg weekly | lifestyle: not reported | 36 | 22 |
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 | Semaglutide 1.0 mg subcutaneous once weekly A2 |
|---|---|---|---|
| age | mean (years) | 54.7 | 58.9 |
| age | sd (years) | 10.9 | 8.9 |
| bmi | mean (kg/m2) | 28.6 | 30.6 |
| bmi | sd (kg/m2) | 4.6 | 5.2 |
| diabetes duration | mean (years) | 8.1 | 11.1 |
| diabetes duration | sd (years) | 7.2 | 9.7 |
| egfr | mean (mL/min/1.73 m2) | 95.4 | 91.1 |
| egfr | sd (mL/min/1.73 m2) | 13.6 | 17.2 |
| established cvd | n | 6 | 6 |
| established cvd | percent | 25 | 27 |
| female | n | 11 | 9 |
| female | percent | 46 | 41 |
| hba1c | mean (percent) | 7.8 | 7.6 |
| hba1c | sd (percent) | 1.4 | 1.2 |
| insulin use | n | 0 | 3 |
| insulin use | percent | 0 | 14 |
| metformin use | n | 18 | 15 |
| metformin use | percent | 75 | 68 |
| other type2 diabetes | n | 21 | 19 |
| other type2 diabetes | percent | 88 | 86 |
| sbp | mean (mmHg) | 131.0 | 135.6 |
| sbp | sd (mmHg) | 19.5 | 18.8 |
| sglt2i use | n | 9 | 8 |
| sglt2i use | percent | 38 | 36 |
| weight | mean (kg) | 75.7 | 84.2 |
| weight | sd (kg) | 15.2 | 17.0 |
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 |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | change | -0.62 percent | 24 | not stated; completers; R0003001:Results | ||
| 26.07 | A2 | change | -0.67 percent | 22 | not stated; completers; R0003001:Results |
Body weight change in kilograms (diabetes) (2 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | change | -0.42 kg | 24 | not stated; completers; R0003001:Results | ||
| 26.07 | A2 | change | -3.41 kg | 22 | not stated; completers; R0003001:Results |
Discontinuation due to adverse events (1 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 2 / | not stated; completers; R0003001:Results |
Discontinuation due to gastrointestinal adverse events (1 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 2 / | not stated; completers; R0003001:Results |
Gallbladder and biliary disease (2 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / | not stated; other; gallstones; R0003001:Results | ||||
| A2 | events | 1 / | not stated; other; gallstones; R0003001:Results |