parallel randomized trial
STRIDE
Effects of Semaglutide on Functional Capacity in Patients With Type 2 Diabetes and Peripheral Arterial Disease
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg weekly | standard of care for PAD and T2D; lifestyle: not reported | 396 | 396 | |
| A2 | Placebo Placebo | standard of care for PAD and T2D; lifestyle: not reported | 396 | 396 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 1.0 mg subcutaneous once weekly A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 66.2 | 67.0 | |
| age | sd (years) | 9.71 | 8.96 | |
| asian | n | 131 | 109 | |
| black | n | 4 | 4 | |
| bmi: less than 30 | percent | 59 | ||
| bmi | median (kg/m2) | 28.7 | ||
| diabetes duration: less than 10 | percent | 39 | ||
| diabetes duration | median (years) | 12.2 | ||
| egfr: 60 or more | n | 676 | ||
| egfr: less than 60 | n | 116 | ||
| established cvd: polyvascular disease | n | 398 | ||
| female | n | 107 | 88 | |
| hba1c: less than 7 | percent | 44 | ||
| hba1c | median (percent) | 7.1 | ||
| hispanic | n | 7 | 6 | |
| insulin use | percent | 31.7 | ||
| other race american indian alaska native | n | 0 | 1 | |
| other race native hawaiian pacific islander | n | 1 | 0 | |
| other race other | n | 1 | 3 | |
| sglt2i use | percent | 35.1 | ||
| white | n | 259 | 279 |
Analyses this trial contributes to
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); 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
Results
53 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (9 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 vs A2 | md | -0.99 percent | -1.14 to -0.84 | hypothetical; full analysis; R0017068:Results | ||
| 52 | A1 vs A2 | md | -1.33 percent | -1.53 to -1.14 | hypothetical; full analysis; hba1c:7_or_more; R0017068:Results | ||
| 52 | A1 | change | -0.63 percent | hypothetical; full analysis; hba1c:less_than_7; R0017068:Results | |||
| 52 | A1 vs A2 | md | -0.56 percent | -0.78 to -0.33 | hypothetical; full analysis; hba1c:less_than_7; R0017068:Results | ||
| 52 | A1 | change | -0.8 percent | 1.1 | 304 | hypothetical; full analysis; registry:outcomes | |
| 52 | A1 | change | -0.96 percent | hypothetical; full analysis; hba1c:7_or_more; R0017068:Results | |||
| 52 | A2 | change | 0.2 percent | 1.1 | 311 | hypothetical; full analysis; registry:outcomes | |
| 52 | A2 | change | -0.08 percent | hypothetical; full analysis; hba1c:less_than_7; R0017068:Results | |||
| 52 | A2 | change | 0.37 percent | hypothetical; full analysis; hba1c:7_or_more; R0017068:Results |
Body weight change in kilograms (diabetes) (9 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 vs A2 | md | -4.64 kg | -5.72 to -3.56 | hypothetical; full analysis; bmi:30_or_more; R0017068:Results | ||
| 52 | A1 | change | -5.2 kg | 4.8 | 310 | hypothetical; full analysis; registry:outcomes | |
| 52 | A1 vs A2 | md | -4.09 kg | -4.79 to -3.40 | hypothetical; full analysis; R0017068:Results | ||
| 52 | A1 | change | -6.08 kg | hypothetical; full analysis; bmi:30_or_more; R0017068:Results | |||
| 52 | A1 | change | -4.47 kg | hypothetical; full analysis; bmi:less_than_30; R0017068:Results | |||
| 52 | A1 vs A2 | md | -3.58 kg | -4.49 to -2.67 | hypothetical; full analysis; bmi:less_than_30; R0017068:Results | ||
| 52 | A2 | change | -1.2 kg | 4.2 | 318 | hypothetical; full analysis; registry:outcomes | |
| 52 | A2 | change | -1.44 kg | hypothetical; full analysis; bmi:30_or_more; R0017068:Results | |||
| 52 | A2 | change | -0.89 kg | hypothetical; full analysis; bmi:less_than_30; R0017068:Results |
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 396 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 395 | not stated; safety; registry:adverse_events |
Systolic blood pressure change (2 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | -4 mmHg | 15 | 310 | hypothetical; full analysis; registry:outcomes | |
| 52 | A2 | change | -1 mmHg | 18 | 319 | hypothetical; full analysis; registry:outcomes |
Acute kidney injury (2 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 396 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 395 | not stated; safety; registry:adverse_events |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 396 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 9 / 395 | not stated; safety; registry:adverse_events |
Hospitalization for heart failure (6 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 396 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A1 | events | 2 / 396 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A1 | events | 2 / 396 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A2 | events | 1 / 395 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A2 | events | 0 / 395 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A2 | events | 1 / 395 | not stated; safety; cardiac failure; registry:adverse_events |
Physical functioning (any instrument) (2 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | 2.98 points | 7.32 | 311 | hypothetical; full analysis; registry:outcomes | |
| 52 | A2 | change | 1.52 points | 7.17 | 320 | hypothetical; full analysis; registry:outcomes |
Health related quality of life total score (any instrument) (3 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | points | 362 | treatment policy; full analysis; registry:outcomes | ||
| 52 | A1 vs A2 | md | 1.00 points | 0.478 to 1.518 | treatment policy; full analysis; registry:outcomes | ||
| 52 | A2 | change | points | 362 | treatment policy; full analysis; registry:outcomes |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 74 / 396 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 78 / 395 | not stated; safety; registry:adverse_events |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 22 / 396 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 395 | not stated; safety; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 396 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 395 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (2 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 396 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 1 / 395 | not stated; safety; cholecystitis acute; registry:adverse_events |
Acute pancreatitis (2 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 396 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 395 | not stated; safety; registry:adverse_events |
Intestinal obstruction or ileus (2 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 396 | not stated; safety; ileus paralytic; registry:adverse_events | ||||
| A2 | events | 0 / 395 | not stated; safety; ileus paralytic; registry:adverse_events |
Pancreatic cancer (4 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 396 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A1 | events | 0 / 396 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A2 | events | 2 / 395 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A2 | events | 1 / 395 | not stated; safety; pancreatic carcinoma; registry:adverse_events |