parallel randomized trial
PIONEER 3
Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 3 mg oral once daily (original tablet) Oral semaglutide 3 mg | metformin with or without sulfonylurea; lifestyle: not reported | 466 | 466 | |
| A2 | Semaglutide 7 mg oral once daily (original tablet) Oral semaglutide 7 mg | metformin with or without sulfonylurea; lifestyle: not reported | 466 | 465 | |
| A3 | Semaglutide 14 mg oral once daily (original tablet) Oral semaglutide 14 mg | metformin with or without sulfonylurea; lifestyle: not reported | 465 | 465 | |
| A4 | Sitagliptin Sitagliptin 100 mg | metformin with or without sulfonylurea; lifestyle: not reported | 467 | 467 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 3 mg oral once daily (original tablet) A1 | Semaglutide 7 mg oral once daily (original tablet) A2 | Semaglutide 14 mg oral once daily (original tablet) A3 | Sitagliptin A4 | Whole trial ALL |
|---|---|---|---|---|---|---|
| age | mean (years) | 58 | 58 | 57 | 58 | |
| age | sd (years) | 10 | 10 | 10 | 10 | |
| asian | n | 56 | 69 | 61 | 59 | |
| black | n | 38 | 38 | 45 | 39 | |
| bmi: 25 to less than 30 | n | 532 | ||||
| bmi: 30 to less than 35 | n | 557 | ||||
| bmi: 35 or more | n | 589 | ||||
| bmi: less than 25 | n | 185 | ||||
| diabetes duration: 10 or more | n | 599 | ||||
| diabetes duration: 5 to less than 10 | n | 687 | ||||
| diabetes duration: less than 5 | n | 577 | ||||
| female | n | 212 | 220 | 218 | 229 | |
| hba1c | mean (percent) | 8.3 | 8.4 | 8.3 | 8.3 | |
| hba1c | sd (percent) | 1.0 | 1.0 | 0.9 | 0.9 | |
| hispanic | n | 76 | 77 | 75 | 93 | |
| other race american indian alaska native | n | 4 | 3 | 5 | 6 | |
| other race native hawaiian pacific islander | n | 1 | 0 | 0 | 0 | |
| other race other | n | 13 | 11 | 20 | 12 | |
| weight background:metformin_and_sulfonylurea | mean (kg) | 90.8 | 89.1 | |||
| weight background:metformin_only | mean (kg) | 91.4 | 92.5 | |||
| white | n | 344 | 330 | 317 | 333 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- HbA1c changeType 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); 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 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); 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
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- HbA1c below 7 percentType 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- 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
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- Percent body weight changeType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Percent body weight changeType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); 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 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 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 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
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (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
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to 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
- VomitingType 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
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
285 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (33 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | md | 0.2 percent | 0.0 to 0.3 | treatment policy; full analysis; registry:outcomes | ||
| 26 | A1 vs A4 | md | 0.2 percent | 0.1 to 0.3 | treatment policy; full analysis; R0024670:Abstract | ||
| 26 | A1 | change | -0.6 percent | 1.0 | 466 | hypothetical; full analysis; registry:outcomes | |
| 26 | A1 | change | -0.6 percent | 1.0 | 466 | treatment policy; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | 0.2 percent | 0.1 to 0.4 | hypothetical; full analysis; R0024670:Abstract | ||
| 26 | A2 | change | -1.0 percent | treatment policy; full analysis; R0024670:Abstract | |||
| 26 | A2 | change | -1.2 percent | 1.1 | 465 | hypothetical; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | -0.3 percent | -0.4 to -0.2 | hypothetical; full analysis; R0024670:Abstract | ||
| 26 | A2 vs A4 | md | -0.2 percent | -0.4 to -0.1 | not stated; full analysis; registry:outcomes | ||
| 26 | A2 | change | -1.1 percent | 1.1 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | -0.3 percent | -0.4 to -0.1 | treatment policy; full analysis; R0024670:Abstract | ||
| 26 | A3 vs A4 | md | -0.5 percent | -0.6 to -0.4 | treatment policy; full analysis; R0024670:Abstract | ||
| 26 | A3 vs A4 | md | -0.6 percent | -0.7 to -0.5 | hypothetical; full analysis; R0024670:Abstract | ||
| 26 | A3 | change | -1.4 percent | 1.0 | 465 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 | change | -1.3 percent | treatment policy; full analysis; R0024670:Abstract | |||
| 26 | A3 | change | -1.3 percent | 1.0 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.8 percent | treatment policy; full analysis; R0024670:Abstract | |||
| 26 | A4 | change | -0.8 percent | 0.9 | 467 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.8 percent | 0.9 | 467 | hypothetical; full analysis; registry:outcomes | |
| 52 | A1 | change | -0.6 percent | 1.1 | 466 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | -1.0 percent | 1.2 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 | change | -1.2 percent | 1.1 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | -0.7 percent | 1.1 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A1 | change | -0.6 percent | 1.1 | 466 | treatment policy; full analysis; registry:outcomes | |
| 78 | A2 | change | -0.9 percent | 1.3 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 vs A4 | md | -0.6 percent | 0.1 | -0.8 to -0.4 | hypothetical; full analysis; background:metformin_only; R0012356:Figure 1 | |
| 78 | A3 | change | -1.1 percent | 1.1 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 | change | -1.0 percent | 0.1 | 220 | hypothetical; full analysis; background:metformin_and_sulfonylurea; R0012356:Figure 1 | |
| 78 | A3 vs A4 | md | -0.7 percent | 0.1 | -1.0 to -0.5 | hypothetical; full analysis; background:metformin_and_sulfonylurea; R0012356:Figure 1 | |
| 78 | A3 | change | -1.2 percent | 0.1 | 245 | hypothetical; full analysis; background:metformin_only; R0012356:Figure 1 | |
| 78 | A4 | change | -0.7 percent | 1.1 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A4 | change | -0.3 percent | 0.1 | 219 | hypothetical; full analysis; background:metformin_and_sulfonylurea; R0012356:Figure 1 | |
| 78 | A4 | change | -0.6 percent | 0.1 | 248 | hypothetical; full analysis; background:metformin_only; R0012356:Figure 1 |
Body weight change in kilograms (diabetes) (28 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | md | -0.6 kg | -1.1 to -0.1 | treatment policy; full analysis; R0024670:Abstract | ||
| 26 | A1 | change | -1.2 kg | 3.3 | 466 | hypothetical; full analysis; registry:outcomes | |
| 26 | A1 vs A4 | md | -0.5 kg | -1.0 to -0.1 | hypothetical; full analysis; R0024670:Abstract | ||
| 26 | A1 | change | -1.2 kg | 3.2 | 466 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | -1.5 kg | -2.0 to -1.1 | hypothetical; full analysis; R0024670:Abstract | ||
| 26 | A2 | change | -2.2 kg | 3.9 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 vs A4 | md | -1.6 kg | -2.0 to -1.1 | treatment policy; full analysis; R0024670:Abstract | ||
| 26 | A2 | change | -2.2 kg | 4.0 | 465 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 | change | -3.2 kg | 3.8 | 465 | hypothetical; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -2.6 kg | -3.1 to -2.1 | hypothetical; full analysis; R0024670:Abstract | ||
| 26 | A3 | change | -3.1 kg | 3.8 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 vs A4 | md | -2.5 kg | -3.0 to -2.0 | treatment policy; full analysis; R0024670:Abstract | ||
| 26 | A4 | change | -0.6 kg | 3.2 | 467 | hypothetical; full analysis; registry:outcomes | |
| 26 | A4 | change | -0.6 kg | 3.2 | 467 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | -1.6 kg | 4.1 | 466 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | -2.5 kg | 4.9 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 | change | -3.5 kg | 4.7 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | -0.7 kg | 3.7 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A1 | change | -1.8 kg | 4.9 | 466 | treatment policy; full analysis; registry:outcomes | |
| 78 | A2 | change | -2.8 kg | 5.4 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 | change | -3.6 kg | 0.3 | 245 | hypothetical; full analysis; background:metformin_only; R0012356:Figure 2 | |
| 78 | A3 vs A4 | md | -2.4 kg | 0.5 | -3.3 to -1.4 | hypothetical; full analysis; background:metformin_and_sulfonylurea; R0012356:Figure 2 | |
| 78 | A3 | change | -3.2 kg | 4.9 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 vs A4 | md | -2.4 kg | 0.5 | -3.3 to -1.5 | hypothetical; full analysis; background:metformin_only; R0012356:Figure 2 | |
| 78 | A3 | change | -3.4 kg | 0.3 | 220 | hypothetical; full analysis; background:metformin_and_sulfonylurea; R0012356:Figure 2 | |
| 78 | A4 | change | -1.0 kg | 4.1 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A4 | change | -1.0 kg | 0.4 | 219 | hypothetical; full analysis; background:metformin_and_sulfonylurea; R0012356:Figure 2 | |
| 78 | A4 | change | -1.2 kg | 0.3 | 248 | hypothetical; full analysis; background:metformin_only; R0012356:Figure 2 |
HbA1c below 7 percent (12 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 116 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 192 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 246 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 144 / 467 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 113 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 168 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 238 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 138 / 467 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A1 | responders | 113 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A2 | responders | 165 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A3 | responders | 191 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A4 | responders | 129 / 467 | treatment policy; full analysis; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (8 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 466 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 23 / 466 | while on treatment; safety; registry:outcomes | ||||
| A2 | events | 24 / 464 | while on treatment; safety; registry:outcomes | ||||
| A2 | events | 0 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 36 / 465 | while on treatment; safety; registry:outcomes | ||||
| A4 | events | 39 / 466 | while on treatment; safety; registry:outcomes | ||||
| A4 | events | 1 / 466 | not stated; safety; registry:adverse_events |
Level 2 or 3 hypoglycemia (episode rate) (4 lines; O04B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | rate | while on treatment; safety; registry:outcomes | |||||
| A2 | rate | while on treatment; safety; registry:outcomes | |||||
| A3 | rate | while on treatment; safety; registry:outcomes | |||||
| A4 | rate | while on treatment; safety; registry:outcomes |
Systolic blood pressure change (12 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -2 mmHg | 14 | 466 | while on treatment; safety; registry:outcomes | |
| 26 | A2 | change | -2 mmHg | 15 | 464 | while on treatment; safety; registry:outcomes | |
| 26 | A3 | change | -3 mmHg | 14 | 465 | while on treatment; safety; registry:outcomes | |
| 26 | A4 | change | -2 mmHg | 15 | 466 | while on treatment; safety; registry:outcomes | |
| 52 | A1 | change | -2 mmHg | 15 | 466 | while on treatment; safety; registry:outcomes | |
| 52 | A2 | change | -4 mmHg | 14 | 464 | while on treatment; safety; registry:outcomes | |
| 52 | A3 | change | -3 mmHg | 15 | 465 | while on treatment; safety; registry:outcomes | |
| 52 | A4 | change | -1 mmHg | 14 | 466 | while on treatment; safety; registry:outcomes | |
| 78 | A1 | change | -2 mmHg | 15 | 466 | while on treatment; safety; registry:outcomes | |
| 78 | A2 | change | -3 mmHg | 15 | 464 | while on treatment; safety; registry:outcomes | |
| 78 | A3 | change | -3 mmHg | 14 | 465 | while on treatment; safety; registry:outcomes | |
| 78 | A4 | change | 0 mmHg | 15 | 466 | while on treatment; safety; registry:outcomes |
Percent body weight change (12 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | percent change | -1.23 percent | 3.57 | 466 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 | percent change | -2.36 percent | 4.09 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 | percent change | -3.44 percent | 4.21 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | percent change | -0.64 percent | 3.38 | 467 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | percent change | -1.65 percent | 4.28 | 466 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | percent change | -2.63 percent | 5.09 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 | percent change | -3.83 percent | 5.14 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | percent change | -0.76 percent | 3.91 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A1 | percent change | -1.87 percent | 4.87 | 466 | treatment policy; full analysis; registry:outcomes | |
| 78 | A2 | percent change | -2.92 percent | 5.67 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 | percent change | -3.47 percent | 5.34 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A4 | percent change | -0.99 percent | 4.39 | 467 | treatment policy; full analysis; registry:outcomes |
Weight loss of 5 percent or more (12 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 53 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 81 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 131 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 45 / 467 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 66 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 118 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 147 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 50 / 467 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A1 | responders | 83 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A2 | responders | 115 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A3 | responders | 139 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A4 | responders | 59 / 467 | treatment policy; full analysis; registry:outcomes |
Weight loss of 10 percent or more (12 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 5 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A2 | responders | 23 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A3 | responders | 29 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 26 | A4 | responders | 8 / 467 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A1 | responders | 13 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A2 | responders | 31 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A3 | responders | 48 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 52 | A4 | responders | 11 / 467 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A1 | responders | 12 / 466 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A2 | responders | 43 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A3 | responders | 46 / 465 | treatment policy; full analysis; registry:outcomes | |||
| 78 | A4 | responders | 17 / 467 | treatment policy; full analysis; registry:outcomes |
Acute kidney injury (4 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 466 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 465 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 466 | not stated; safety; registry:adverse_events |
All cause mortality (4 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 466 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 4 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 465 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 3 / 466 | not stated; safety; registry:adverse_events |
Hospitalization for heart failure (16 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 466 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A1 | events | 0 / 466 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A1 | events | 3 / 466 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A1 | events | 1 / 466 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A2 | events | 1 / 464 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A3 | events | 2 / 465 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A4 | events | 1 / 466 | not stated; safety; cardiac failure acute; registry:adverse_events | ||||
| A4 | events | 2 / 466 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A4 | events | 0 / 466 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A4 | events | 0 / 466 | not stated; safety; cardiac failure; registry:adverse_events |
SF-36 physical component summary change (12 lines; O24A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 0.56 points | 6.42 | 466 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 | change | 0.98 points | 5.72 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 | change | 0.63 points | 6.00 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | 0.69 points | 6.24 | 467 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | 0.31 points | 6.50 | 466 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | 0.36 points | 6.82 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 | change | 0.09 points | 6.47 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | 0.31 points | 6.54 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A1 | change | 0.46 points | 6.74 | 466 | treatment policy; full analysis; registry:outcomes | |
| 78 | A2 | change | 0.71 points | 6.24 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 | change | 0.67 points | 6.29 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A4 | change | 0.70 points | 6.38 | 467 | treatment policy; full analysis; registry:outcomes |
Physical functioning (any instrument) (24 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 3.52 points | 16.48 | 466 | treatment policy; full analysis; registry:outcomes | |
| 26 | A1 | change | 0.37 points | 7.25 | 466 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 | change | 2.78 points | 16.13 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 | change | 1.12 points | 6.52 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 | change | 3.20 points | 18.48 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 | change | 0.63 points | 7.13 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | 1.70 points | 16.54 | 467 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | 0.46 points | 6.73 | 467 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | 2.28 points | 17.00 | 466 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | 0.29 points | 7.14 | 466 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | 3.24 points | 18.17 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | 0.64 points | 7.34 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 | change | 3.19 points | 19.76 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 | change | 0.36 points | 7.30 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | 1.22 points | 18.21 | 467 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | 0.06 points | 7.30 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A1 | change | 2.55 points | 17.86 | 466 | treatment policy; full analysis; registry:outcomes | |
| 78 | A1 | change | 0.06 points | 8.09 | 466 | treatment policy; full analysis; registry:outcomes | |
| 78 | A2 | change | 4.04 points | 17.99 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A2 | change | 0.94 points | 6.91 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 | change | 3.76 points | 18.78 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 | change | 0.54 points | 7.98 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A4 | change | 2.54 points | 18.96 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A4 | change | 0.09 points | 7.60 | 467 | treatment policy; full analysis; registry:outcomes |
Health related quality of life total score (any instrument) (12 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 2.88 points | 12.11 | 466 | treatment policy; full analysis; registry:outcomes | |
| 26 | A2 | change | 3.62 points | 13.37 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A3 | change | 2.95 points | 13.87 | 465 | treatment policy; full analysis; registry:outcomes | |
| 26 | A4 | change | 2.05 points | 12.05 | 467 | treatment policy; full analysis; registry:outcomes | |
| 52 | A1 | change | 2.67 points | 13.01 | 466 | treatment policy; full analysis; registry:outcomes | |
| 52 | A2 | change | 4.43 points | 13.59 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A3 | change | 3.64 points | 15.22 | 465 | treatment policy; full analysis; registry:outcomes | |
| 52 | A4 | change | 2.17 points | 12.86 | 467 | treatment policy; full analysis; registry:outcomes | |
| 78 | A1 | change | 3.45 points | 13.32 | 466 | treatment policy; full analysis; registry:outcomes | |
| 78 | A2 | change | 4.73 points | 14.07 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A3 | change | 3.77 points | 14.97 | 465 | treatment policy; full analysis; registry:outcomes | |
| 78 | A4 | change | 3.16 points | 13.76 | 467 | treatment policy; full analysis; registry:outcomes |
Serious adverse events (8 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13.7 | 466 | not stated; other; R0024670:Abstract | |||
| A1 | events | 64 / 466 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 10.1 | 466 | not stated; other; R0024670:Abstract | |||
| A2 | events | 47 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 9.5 | 465 | not stated; other; R0024670:Abstract | |||
| A3 | events | 44 / 465 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 12.4 | 467 | not stated; other; R0024670:Abstract | |||
| A4 | events | 58 / 466 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (4 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5.6 | 466 | not stated; other; R0024670:Abstract | |||
| A2 | events | 5.8 | 466 | not stated; other; R0024670:Abstract | |||
| A3 | events | 11.6 | 465 | not stated; other; R0024670:Abstract | |||
| A4 | events | 5.2 | 467 | not stated; other; R0024670:Abstract |
Nausea (8 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 466 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 34 / 466 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 62 / 464 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 70 / 465 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 31 / 466 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 466 | not stated; safety; registry:adverse_events |
Vomiting (8 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13 / 466 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 466 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 27 / 464 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 42 / 465 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 19 / 466 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 466 | not stated; safety; registry:adverse_events |
Diarrhea (8 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 44 / 466 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 466 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 53 / 464 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 56 / 465 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 465 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 37 / 466 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 466 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (20 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 466 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 1 / 466 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A1 | events | 0 / 466 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A1 | events | 0 / 466 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A1 | events | 0 / 466 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 1 / 464 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 2 / 465 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 1 / 465 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 1 / 466 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A4 | events | 2 / 466 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 3 / 466 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 466 | not stated; safety; cholecystitis chronic; registry:adverse_events | ||||
| A4 | events | 1 / 466 | not stated; safety; cholecystitis infective; registry:adverse_events |
Acute pancreatitis (4 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 466 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 465 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 466 | not stated; safety; registry:adverse_events |
Thyroid cancer (any) (4 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 466 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 466 | not stated; safety; registry:adverse_events |
Diabetic retinopathy complications (12 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 27 / 466 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A1 | events | 0 / 466 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A1 | events | 0 / 466 | not stated; safety; retinopathy proliferative; registry:adverse_events | ||||
| A2 | events | 24 / 464 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; retinopathy proliferative; registry:adverse_events | ||||
| A3 | events | 16 / 465 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; retinopathy proliferative; registry:adverse_events | ||||
| A4 | events | 26 / 466 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A4 | events | 1 / 466 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A4 | events | 1 / 466 | not stated; safety; retinopathy proliferative; registry:adverse_events |
Pancreatic cancer (4 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 466 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A2 | events | 0 / 464 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A3 | events | 0 / 465 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events | ||||
| A4 | events | 1 / 466 | not stated; safety; pancreatic carcinoma metastatic; registry:adverse_events |