parallel randomized trial
SUSTAIN FORTE
Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1.0 mg | metformin with or without sulfonylurea; lifestyle: not reported | 481 | 481 | |
| A2 | Semaglutide 2.0 mg subcutaneous once weekly Semaglutide 2.0 mg | metformin with or without sulfonylurea; lifestyle: not reported | 480 | 480 |
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 | Semaglutide 2.0 mg subcutaneous once weekly A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 58.2 | 57.9 | 58.0 |
| age | sd (years) | 9.9 | 10.0 | 10.0 |
| asian | n | 36 | 33 | 69 |
| black | n | 17 | 26 | 43 |
| bmi | mean (kg/m2) | 34.6 | ||
| bmi | sd (kg/m2) | 7.0 | ||
| diabetes duration | mean (years) | 9.5 | ||
| diabetes duration | sd (years) | 6.2 | ||
| egfr | mean (mL/min/1.73 m2) | 93.4 | ||
| egfr | sd (mL/min/1.73 m2) | 16.9 | ||
| female | n | 197 | 201 | 398 |
| female | percent | 41.4 | ||
| hba1c | mean (percent) | 8.9 | ||
| hba1c | sd (percent) | 0.6 | ||
| hispanic | n | 59 | 52 | 111 |
| sbp | mean (mmHg) | 134.4 | ||
| sbp | sd (mmHg) | 14.0 | ||
| weight | mean (kg) | 99.3 | ||
| weight | sd (kg) | 23.5 | ||
| white | n | 427 | 420 | 847 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 40 to 104 (target week 68); 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
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
42 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 |
|---|---|---|---|---|---|---|---|
| 40 | A1 | change | -1.9 percent | 1.0 | 481 | treatment policy; full analysis; registry:outcomes | |
| 40 | A1 | change | -2.0 percent | 1.0 | 481 | hypothetical; full analysis; registry:outcomes | |
| 40 | A2 vs A1 | md | -0.23 percent | -0.36 to -0.11 | not stated; full analysis; registry:outcomes | ||
| 40 | A2 vs A1 | md | -0.18 percent | -0.31 to -0.04 | not stated; full analysis; registry:outcomes | ||
| 40 | A2 | change | -2.2 percent | 1.1 | 480 | treatment policy; full analysis; registry:outcomes | |
| 40 | A2 | change | -2.2 percent | 1.0 | 480 | hypothetical; full analysis; registry:outcomes |
Body weight change in kilograms (diabetes) (4 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 40 | A1 | change | -6.0 kg | 5.8 | 481 | hypothetical; full analysis; registry:outcomes | |
| 40 | A1 | change | -5.7 kg | 5.9 | 481 | treatment policy; full analysis; registry:outcomes | |
| 40 | A2 | change | -7.0 kg | 5.8 | 480 | hypothetical; full analysis; registry:outcomes | |
| 40 | A2 | change | -6.7 kg | 5.9 | 480 | treatment policy; full analysis; registry:outcomes |
HbA1c below 7 percent (2 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 40 | A1 | responders | 57.5 | 481 | not stated; full analysis; registry:outcomes | ||
| 40 | A2 | responders | 67.6 | 480 | not stated; full analysis; registry:outcomes |
Weight loss of 5 percent or more (2 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 40 | A1 | responders | 51.3 | 481 | not stated; full analysis; registry:outcomes | ||
| 40 | A2 | responders | 59.2 | 480 | not stated; full analysis; registry:outcomes |
Weight loss of 10 percent or more (2 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 40 | A1 | responders | 22.6 | 481 | not stated; full analysis; registry:outcomes | ||
| 40 | A2 | responders | 28.4 | 480 | not stated; full analysis; registry:outcomes |
Acute kidney injury (2 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 480 | not stated; safety; Acute kidney injury; registry:adverse_events | ||||
| A2 | events | 2 / 479 | not stated; safety; Acute kidney injury; registry:adverse_events |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 480 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 479 | not stated; safety; registry:adverse_events |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 25 / 480 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 21 / 479 | not stated; safety; registry:adverse_events |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 70 / 480 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 480 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 69 / 479 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 479 | not stated; safety; registry:adverse_events |
Vomiting (4 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 32 / 480 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 480 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 37 / 479 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 479 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 42 / 480 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 45 / 479 | not stated; safety; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 480 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 479 | 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 | 1 / 480 | not stated; safety; Cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 479 | not stated; safety; Cholelithiasis; registry:adverse_events |
Thyroid cancer (any) (2 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 480 | not stated; safety; papillary thyroid cancer; registry:adverse_events | ||||
| A2 | events | 0 / 479 | not stated; safety; papillary thyroid cancer; registry:adverse_events |
Nonarteritic anterior ischemic optic neuropathy (2 lines; O34)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 480 | not stated; safety; optic ischaemic neuropathy; registry:adverse_events | ||||
| A2 | events | 1 / 479 | not stated; safety; optic ischaemic neuropathy; registry:adverse_events |
Pancreatic cancer (2 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 480 | not stated; safety; adenocarcinoma pancreas; registry:adverse_events | ||||
| A2 | events | 1 / 479 | not stated; safety; adenocarcinoma pancreas; registry:adverse_events |