parallel randomized trial
AWARD-1
A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg | metformin at least 1500 mg/day and pioglitazone at least 30 mg/day; lifestyle: not reported | 279 | 271 | |
| A2 | Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg | metformin at least 1500 mg/day and pioglitazone at least 30 mg/day; lifestyle: not reported | 280 | 269 | |
| A3 | Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug BID | metformin at least 1500 mg/day and pioglitazone at least 30 mg/day; lifestyle: not reported | 278 | 266 | |
| A4 | Placebo Placebo | metformin at least 1500 mg/day and pioglitazone at least 30 mg/day; lifestyle: not reported | 141 | 119 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Dulaglutide 1.5 mg subcutaneous once weekly A1 | Dulaglutide 0.75 mg subcutaneous once weekly A2 | Exenatide 10 ug subcutaneous twice daily A3 | Placebo A4 | Whole trial ALL |
|---|---|---|---|---|---|---|
| age | mean (years) | 56.25 | 55.79 | 55.45 | 54.56 | |
| age | sd (years) | 9.72 | 9.45 | 10.15 | 10.01 | |
| asian | n | 6 | 8 | 4 | 6 | |
| black | n | 24 | 24 | 18 | 10 | |
| bmi | mean (kg/m2) | 33.09 | 33.00 | 33.54 | 32.90 | |
| bmi | sd (kg/m2) | 5.33 | 5.50 | 5.36 | 5.66 | |
| diabetes duration | mean (years) | 8.76 | 8.78 | 8.84 | 8.60 | |
| diabetes duration | sd (years) | 5.59 | 5.47 | 5.71 | 5.78 | |
| egfr: <60 | n | 27 | ||||
| egfr: <60 | percent | 2.8 | ||||
| female | n | 116 | 112 | 120 | 58 | |
| hba1c | mean (percent) | 8.10 | 8.05 | 8.07 | 8.06 | |
| hba1c | sd (percent) | 1.34 | 1.24 | 1.34 | 1.31 | |
| hispanic | n | 93 | 102 | 91 | 45 | |
| other race american indian | n | 40 | 37 | 38 | 20 | |
| other race multiple | n | 3 | 3 | 3 | 2 | |
| other race pacific islander | n | 1 | 1 | 1 | 0 | |
| other race unknown | n | 0 | 0 | 1 | 0 | |
| uacr: >300 | n | 23 | ||||
| uacr: >300 | percent | 2.4 | ||||
| weight | mean (kg) | 96.22 | 95.53 | 97.37 | 94.12 | |
| weight | sd (kg) | 19.63 | 20.56 | 18.87 | 19.28 | |
| white | n | 205 | 207 | 211 | 103 |
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 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 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 20 to 36 (target week 26); 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 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 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
- 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
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
224 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (41 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -2.37 percent | -2.56 to -2.17 | not stated; modified itt; hba1c:>=8.5; R0014882:Supplement Table 3 | ||
| 26 | A1 | change | -1.56 percent | -1.74 to -1.38 | not stated; modified itt; diabetes_duration:5_10; R0014882:Supplement Table 3 | ||
| 26 | A1 | change | -1.39 percent | -1.54 to -1.25 | not stated; modified itt; sex:male; R0014882:Supplement Table 3 | ||
| 26 | A1 | change | -1.16 percent | -1.31 to -1.02 | not stated; modified itt; hba1c:<8.5; R0014882:Supplement Table 3 | ||
| 26 | A1 vs A4 | md | -1.05 percent | -1.22 to -0.88 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A1 vs A3 | md | -0.52 percent | -0.66 to -0.39 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A1 | change | -1.65 percent | -1.81 to -1.49 | not stated; modified itt; sex:female; R0014882:Supplement Table 3 | ||
| 26 | A1 | change | -1.51 percent | 0.06 | 271 | hypothetical; modified itt; registry:outcomes | |
| 26 | A1 | change | -1.44 percent | -1.64 to -1.24 | not stated; modified itt; diabetes_duration:<5; R0014882:Supplement Table 3 | ||
| 26 | A1 | change | -1.50 percent | -1.67 to -1.34 | not stated; modified itt; diabetes_duration:>=10; R0014882:Supplement Table 3 | ||
| 26 | A2 | change | -2.12 percent | -2.32 to -1.92 | not stated; modified itt; hba1c:>=8.5; R0014882:Supplement Table 3 | ||
| 26 | A2 | change | -1.30 percent | 0.06 | 269 | hypothetical; modified itt; registry:outcomes | |
| 26 | A2 | change | -1.21 percent | -1.38 to -1.04 | not stated; modified itt; diabetes_duration:5_10; R0014882:Supplement Table 3 | ||
| 26 | A2 | change | -1.23 percent | -1.37 to -1.08 | not stated; modified itt; sex:male; R0014882:Supplement Table 3 | ||
| 26 | A2 | change | -0.94 percent | -1.08 to -0.80 | not stated; modified itt; hba1c:<8.5; R0014882:Supplement Table 3 | ||
| 26 | A2 | change | -1.38 percent | -1.55 to -1.22 | not stated; modified itt; diabetes_duration:>=10; R0014882:Supplement Table 3 | ||
| 26 | A2 | change | -1.28 percent | -1.49 to -1.07 | not stated; modified itt; diabetes_duration:<5; R0014882:Supplement Table 3 | ||
| 26 | A2 | change | -1.39 percent | -1.55 to -1.22 | not stated; modified itt; sex:female; R0014882:Supplement Table 3 | ||
| 26 | A2 vs A4 | md | -0.84 percent | -1.01 to -0.67 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A2 vs A3 | md | -0.31 percent | -0.44 to -0.18 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A3 | change | -0.99 percent | -1.14 to -0.83 | not stated; modified itt; sex:female; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.99 percent | 0.06 | 266 | hypothetical; modified itt; registry:outcomes | |
| 26 | A3 | change | -0.97 percent | -1.12 to -0.83 | not stated; modified itt; sex:male; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.93 percent | -1.13 to -0.73 | not stated; modified itt; diabetes_duration:<5; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -1.02 percent | -1.19 to -0.85 | not stated; modified itt; diabetes_duration:>=10; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -1.00 percent | -1.17 to -0.82 | not stated; modified itt; diabetes_duration:5_10; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.64 percent | -0.78 to -0.50 | not stated; modified itt; hba1c:<8.5; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -1.86 percent | -2.07 to -1.66 | not stated; modified itt; hba1c:>=8.5; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.17 percent | -0.36 to 0.02 | not stated; modified itt; hba1c:<8.5; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.53 percent | -0.77 to -0.28 | not stated; modified itt; diabetes_duration:>=10; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.49 percent | -0.76 to -0.22 | not stated; modified itt; diabetes_duration:<5; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.44 percent | -0.68 to -0.21 | not stated; modified itt; sex:female; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.76 percent | -1.07 to -0.44 | not stated; modified itt; hba1c:>=8.5; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.46 percent | -0.65 to -0.26 | not stated; modified itt; sex:male; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.38 percent | -0.64 to -0.12 | not stated; modified itt; diabetes_duration:5_10; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.46 percent | 0.08 | 119 | hypothetical; modified itt; registry:outcomes | |
| 52 | A1 vs A3 | md | -0.56 percent | -0.73 to -0.39 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A1 | change | -1.36 percent | 0.08 | 271 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 vs A3 | md | -0.27 percent | -0.44 to -0.11 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A2 | change | -1.07 percent | 0.08 | 269 | hypothetical; modified itt; registry:outcomes | |
| 52 | A3 | change | -0.80 percent | 0.08 | 266 | hypothetical; modified itt; registry:outcomes |
Body weight change in kilograms (diabetes) (46 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | md | -2.72 kg | -3.58 to -1.85 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A1 | change | -0.92 kg | -1.62 to -0.22 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 26 | A1 | change | -0.78 kg | -1.75 to 0.19 | not stated; modified itt; diabetes_duration:<5; R0014882:Table 2 | ||
| 26 | A1 | change | -1.34 kg | 0.25 | 259 | hypothetical; modified itt; registry:outcomes | |
| 26 | A1 | change | -1.41 kg | -2.05 to -0.77 | not stated; modified itt; hba1c:<8.5; R0014882:Table 2 | ||
| 26 | A1 | change | -1.08 kg | -1.96 to -0.19 | not stated; modified itt; hba1c:>=8.5; R0014882:Table 2 | ||
| 26 | A1 | change | -1.30 kg | 279 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A1 | change | -1.69 kg | -2.57 to -0.82 | not stated; modified itt; diabetes_duration:5_10; R0014882:Table 2 | ||
| 26 | A1 vs A3 | md | -0.20 kg | -0.88 to 0.49 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A1 | change | -1.87 kg | -2.66 to -1.08 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26 | A1 | change | -1.37 kg | -2.16 to -0.57 | not stated; modified itt; diabetes_duration:>=10; R0014882:Table 2 | ||
| 26 | A2 | change | 0.07 kg | -0.57 to 0.71 | not stated; modified itt; hba1c:<8.5; R0014882:Table 2 | ||
| 26 | A2 | change | 0.18 kg | 0.25 | 253 | hypothetical; modified itt; registry:outcomes | |
| 26 | A2 vs A3 | md | 1.33 kg | 0.64 to 2.01 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A2 vs A4 | md | -1.19 kg | -2.06 to -0.33 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A2 | change | 0.20 kg | 280 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A2 | change | 0.15 kg | -0.53 to 0.84 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 26 | A2 | change | 0.25 kg | -0.57 to 1.06 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26 | A2 | change | -0.50 kg | -1.52 to 0.52 | not stated; modified itt; diabetes_duration:<5; R0014882:Table 2 | ||
| 26 | A2 | change | 0.20 kg | -0.60 to 0.99 | not stated; modified itt; diabetes_duration:>=10; R0014882:Table 2 | ||
| 26 | A2 | change | 0.50 kg | -0.38 to 1.37 | not stated; modified itt; hba1c:>=8.5; R0014882:Table 2 | ||
| 26 | A2 | change | 0.53 kg | -0.31 to 1.38 | not stated; modified itt; diabetes_duration:5_10; R0014882:Table 2 | ||
| 26 | A3 | change | -1.23 kg | -1.94 to -0.52 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 26 | A3 | change | -1.01 kg | -1.64 to -0.38 | not stated; modified itt; hba1c:<8.5; R0014882:Table 2 | ||
| 26 | A3 | change | -1.57 kg | -2.37 to -0.77 | not stated; modified itt; diabetes_duration:>=10; R0014882:Table 2 | ||
| 26 | A3 vs A4 | md | -2.52 kg | -3.39 to -1.65 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A3 | change | -1.07 kg | 276 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A3 | change | -1.14 kg | 0.26 | 245 | hypothetical; modified itt; registry:outcomes | |
| 26 | A3 | change | -0.89 kg | -1.67 to -0.11 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26 | A3 | change | -0.62 kg | -1.46 to 0.23 | not stated; modified itt; diabetes_duration:5_10; R0014882:Table 2 | ||
| 26 | A3 | change | -1.08 kg | -2.09 to -0.08 | not stated; modified itt; diabetes_duration:<5; R0014882:Table 2 | ||
| 26 | A3 | change | -1.19 kg | -2.10 to -0.29 | not stated; modified itt; hba1c:>=8.5; R0014882:Table 2 | ||
| 26 | A4 | change | 1.35 kg | 0.16 to 2.55 | not stated; modified itt; diabetes_duration:5_10; R0014882:Table 2 | ||
| 26 | A4 | change | 1.37 kg | 0.37 | 109 | hypothetical; modified itt; registry:outcomes | |
| 26 | A4 | change | 1.24 kg | 141 | not stated; modified itt; R0022281:Table 3 | ||
| 26 | A4 | change | 0.85 kg | -0.39 to 2.09 | not stated; modified itt; diabetes_duration:<5; R0014882:Table 2 | ||
| 26 | A4 | change | 1.21 kg | 0.12 to 2.29 | not stated; modified itt; diabetes_duration:>=10; R0014882:Table 2 | ||
| 26 | A4 | change | 1.84 kg | 0.98 to 2.70 | not stated; modified itt; hba1c:<8.5; R0014882:Table 2 | ||
| 26 | A4 | change | 0.12 kg | -1.01 to 1.25 | not stated; modified itt; hba1c:>=8.5; R0014882:Table 2 | ||
| 26 | A4 | change | 1.64 kg | 0.57 to 2.71 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26 | A4 | change | 0.95 kg | 0.05 to 1.85 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 52 | A1 vs A3 | md | -0.32 kg | -1.25 to 0.62 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A1 | change | -1.08 kg | 0.34 | 238 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 | change | 0.49 kg | 0.34 | 231 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 vs A3 | md | 1.25 kg | 0.32 to 2.19 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A3 | change | -0.76 kg | 0.35 | 210 | hypothetical; modified itt; registry:outcomes |
HbA1c below 7 percent (14 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | or | 13.1 | 7.4 to 23.4 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A1 | responders | 78.2 | 271 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A1 vs A3 | or | 6.2 | 3.9 to 10.1 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A2 | responders | 65.8 | 269 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A2 vs A3 | or | 2.3 | 1.5 to 3.5 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A2 vs A4 | or | 4.8 | 2.8 to 8.0 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A3 | responders | 52.3 | 266 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A3 vs A4 | or | 2.1 | 1.3 to 3.5 | hypothetical; modified itt; registry:outcomes | ||
| 26 | A4 | responders | 42.9 | 119 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A1 vs A3 | or | 3.7 | 2.4 to 5.6 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A1 | responders | 70.8 | 271 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A2 vs A3 | or | 1.7 | 1.1 to 2.5 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A2 | responders | 59.1 | 269 | hypothetical; modified itt; registry:outcomes | ||
| 52 | A3 | responders | 49.2 | 266 | hypothetical; modified itt; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (10 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 279 | not stated; safety; registry:outcomes | ||||
| A1 | events | 0 | 279 | not stated; modified itt; R0022281:Table 3 | |||
| A1 | events | 0 / 279 | not stated; safety; registry:outcomes | ||||
| A2 | events | 0 / 280 | not stated; safety; registry:outcomes | ||||
| A2 | events | 0 / 280 | not stated; safety; registry:outcomes | ||||
| A2 | events | 2.5 | 280 | not stated; modified itt; R0022281:Table 3 | |||
| A3 | events | 5.4 | 276 | not stated; modified itt; R0022281:Table 3 | |||
| A3 | events | 1 / 276 | not stated; safety; registry:outcomes | ||||
| A4 | events | 0 / 141 | not stated; safety; registry:outcomes | ||||
| A4 | events | 0 | 141 | not stated; modified itt; R0022281:Table 3 |
Systolic blood pressure change (7 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 0.11 mmHg | 0.83 | 263 | not stated; modified itt; registry:outcomes | |
| 26 | A2 | change | -0.36 mmHg | 0.82 | 266 | not stated; modified itt; registry:outcomes | |
| 26 | A3 | change | 0.06 mmHg | 0.83 | 259 | not stated; modified itt; registry:outcomes | |
| 26 | A4 | change | 3.40 mmHg | 1.13 | 127 | not stated; modified itt; registry:outcomes | |
| 52 | A1 | change | 0.83 mmHg | 0.87 | 248 | not stated; modified itt; registry:outcomes | |
| 52 | A2 | change | 1.62 mmHg | 0.85 | 256 | not stated; modified itt; registry:outcomes | |
| 52 | A3 | change | 0.02 mmHg | 0.88 | 238 | not stated; modified itt; registry:outcomes |
All cause mortality (4 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 279 | not stated; randomized; registry:flow | ||||
| A2 | events | 1 / 280 | not stated; randomized; registry:flow | ||||
| A3 | events | 0 / 278 | not stated; randomized; registry:flow | ||||
| A4 | events | 0 / 141 | not stated; randomized; registry:flow |
Physical functioning (any instrument) (7 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 0.18 points | 0.27 | 270 | hypothetical; modified itt; registry:outcomes | |
| 26 | A2 | change | 0.12 points | 0.27 | 267 | hypothetical; modified itt; registry:outcomes | |
| 26 | A3 | change | 0.47 points | 0.27 | 266 | hypothetical; modified itt; registry:outcomes | |
| 26 | A4 | change | 0.03 points | 0.36 | 119 | hypothetical; modified itt; registry:outcomes | |
| 52 | A1 | change | 0.18 points | 0.29 | 270 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 | change | -0.18 points | 0.29 | 267 | hypothetical; modified itt; registry:outcomes | |
| 52 | A3 | change | 0.35 points | 0.29 | 266 | hypothetical; modified itt; registry:outcomes |
Health related quality of life total score (any instrument) (7 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 0.01 points | 0.01 | 270 | hypothetical; modified itt; registry:outcomes | |
| 26 | A2 | change | 0.01 points | 0.01 | 266 | hypothetical; modified itt; registry:outcomes | |
| 26 | A3 | change | 0.00 points | 0.01 | 264 | hypothetical; modified itt; registry:outcomes | |
| 26 | A4 | change | -0.00 points | 0.02 | 119 | hypothetical; modified itt; registry:outcomes | |
| 52 | A1 | change | 0.02 points | 0.01 | 270 | hypothetical; modified itt; registry:outcomes | |
| 52 | A2 | change | 0.01 points | 0.01 | 266 | hypothetical; modified itt; registry:outcomes | |
| 52 | A3 | change | -0.00 points | 0.01 | 264 | hypothetical; modified itt; registry:outcomes |
Serious adverse events (7 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 18 / 279 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 12 / 279 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 15 / 280 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 22 / 280 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 15 / 278 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 27 / 278 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 12 / 141 | 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 | 9 / 279 | not stated; randomized; registry:flow | ||||
| A2 | events | 4 / 280 | not stated; randomized; registry:flow | ||||
| A3 | events | 10 / 278 | not stated; randomized; registry:flow | ||||
| A4 | events | 3 / 141 | not stated; randomized; registry:flow |
Nausea (7 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 78 / 279 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 82 / 279 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 45 / 280 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 47 / 280 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 77 / 278 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 71 / 278 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 8 / 141 | not stated; safety; registry:adverse_events |
Vomiting (7 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 48 / 279 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 47 / 279 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 17 / 280 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 17 / 280 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 34 / 278 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 30 / 278 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 2 / 141 | not stated; safety; registry:adverse_events |
Diarrhea (7 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 37 / 279 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 31 / 279 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 26 / 280 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 22 / 280 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 22 / 278 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 16 / 278 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 8 / 141 | not stated; safety; registry:adverse_events |
Constipation (7 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 279 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 16 / 279 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 5 / 280 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 5 / 280 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 5 / 278 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 5 / 278 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 2 / 141 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (21 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 279 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A1 | events | 0 / 279 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A1 | events | 0 / 279 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 0 / 279 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 2 / 279 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A1 | events | 1 / 279 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 1 / 278 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A3 | events | 1 / 278 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 278 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 278 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 278 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A3 | events | 0 / 278 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 141 | not stated; safety; biliary colic; registry:adverse_events | ||||
| A4 | events | 0 / 141 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A4 | events | 0 / 141 | not stated; safety; cholecystitis acute; registry:adverse_events |
Acute pancreatitis (14 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 279 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A1 | events | 0 / 279 | not stated; safety; registry:outcomes | ||||
| A1 | events | 1 / 279 | not stated; safety; registry:outcomes | ||||
| A1 | events | 0 / 279 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; registry:outcomes | ||||
| A2 | events | 0 / 280 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; registry:outcomes | ||||
| A3 | events | 0 / 276 | not stated; safety; registry:outcomes | ||||
| A3 | events | 1 / 278 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 276 | not stated; safety; registry:outcomes | ||||
| A3 | events | 1 / 278 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 141 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A4 | events | 0 / 141 | not stated; safety; registry:outcomes |
Suicidal ideation or behavior (7 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 279 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A1 | events | 0 / 279 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A2 | events | 1 / 280 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A2 | events | 1 / 280 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A3 | events | 0 / 278 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A3 | events | 0 / 278 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A4 | events | 0 / 141 | not stated; safety; suicidal ideation; registry:adverse_events |
Pancreatic cancer (7 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 279 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A1 | events | 1 / 279 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A2 | events | 0 / 280 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A3 | events | 0 / 278 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A3 | events | 0 / 278 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A4 | events | 0 / 141 | not stated; safety; pancreatic carcinoma; registry:adverse_events |