parallel randomized trial
NCT00734474
A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
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; lifestyle: not reported | 304 | 304 | |
| A2 | Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg | metformin at least 1500 mg/day; lifestyle: not reported | 302 | 302 | |
| A3 | Sitagliptin Sitagliptin 100 mg | metformin at least 1500 mg/day; lifestyle: not reported | 315 | 315 | |
| A4 | Placebo Placebo, switched to sitagliptin after week 26 | metformin at least 1500 mg/day; lifestyle: not reported | 177 | 177 | |
| A5 | Dulaglutide 3.0 mg subcutaneous once weekly Dulaglutide 3.0 mg (dose finding) | metformin at least 1500 mg/day; lifestyle: not reported | 15 | 8 | |
| A6 | dulaglutide Dulaglutide 2.0 mg (dose finding) | metformin at least 1500 mg/day; lifestyle: not reported | 30 | 25 | |
| A7 | dulaglutide Dulaglutide 1.0 mg (dose finding) | metformin at least 1500 mg/day; lifestyle: not reported | 10 | 8 | |
| A8 | dulaglutide Dulaglutide 0.5 mg (dose finding) | metformin at least 1500 mg/day; lifestyle: not reported | 25 | 21 | |
| A9 | dulaglutide Dulaglutide 0.25 mg (dose finding) | metformin at least 1500 mg/day; lifestyle: not reported | 24 | 23 |
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 | Sitagliptin A3 | Placebo A4 | Dulaglutide 3.0 mg subcutaneous once weekly A5 | Dulaglutide 2.0 mg (dose finding) A6 | Dulaglutide 1.0 mg (dose finding) A7 | Dulaglutide 0.5 mg (dose finding) A8 | Dulaglutide 0.25 mg (dose finding) A9 | Whole trial ALL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| age: less than 65 | n | 1048 | |||||||||
| age: less than 65 | percent | 87.2 | |||||||||
| age | mean (years) | 54 | 54 | 54 | 55 | 52.81 | 52.56 | 55.38 | 54.70 | 56.51 | |
| age | sd (years) | 10 | 10 | 10 | 9 | 10.66 | 10.95 | 8.71 | 9.72 | 6.56 | |
| asian | n | 285 | |||||||||
| asian | percent | 23.7 | |||||||||
| black | n | 16 | 12 | 7 | 9 | 1 | 3 | 0 | 2 | 0 | |
| black | percent | 5 | 4 | 2 | 5 | ||||||
| bmi | mean (kg/m2) | 31 | 31 | 31 | 31 | 31.02 | 31.45 | 33.89 | 32.53 | 31.06 | |
| bmi | sd (kg/m2) | 5 | 4 | 4 | 4 | 4.69 | 4.88 | 4.44 | 4.61 | 3.94 | |
| diabetes duration | mean (years) | 7 | 7 | 7 | 7 | 6.79 | 6.92 | 7.04 | 6.75 | 6.74 | |
| diabetes duration | sd (years) | 6 | 5 | 5 | 5 | 6.34 | 5.12 | 4.57 | 3.99 | 4.20 | |
| egfr: less than 60 | n | 25 | |||||||||
| egfr: less than 60 | percent | 2.1 | |||||||||
| female | n | 158 | 168 | 164 | 87 | 10 | 22 | 7 | 12 | 15 | |
| female | percent | 52 | 56 | 52 | 49 | ||||||
| hba1c | mean (percent) | 8.1 | 8.2 | 8.1 | 8.1 | 7.95 | 8.36 | 7.87 | 8.30 | 7.82 | |
| hba1c | sd (percent) | 1.1 | 1.1 | 1.1 | 1.1 | 1.11 | 1.04 | 0.62 | 1.34 | 0.80 | |
| hispanic | n | 54 | 51 | 67 | 38 | 7 | 8 | 6 | 14 | 6 | |
| hispanic | percent | 18 | 17 | 21 | 22 | ||||||
| other race aboriginal | n | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| other race aboriginal | percent | 0 | 0 | 0 | |||||||
| other race american indian alaska native | n | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| other race american indian alaska native | percent | 0 | 0 | 0 | |||||||
| other race east asian | n | 50 | 47 | 52 | 28 | 0 | 6 | 0 | 0 | 5 | |
| other race east asian | percent | 16 | 16 | 17 | 16 | ||||||
| other race west asian | n | 27 | 30 | 28 | 11 | 0 | 0 | 0 | 0 | 1 | |
| other race west asian | percent | 9 | 10 | 9 | 6 | ||||||
| sbp | mean (mmHg) | 129 | 128 | 127 | 128 | ||||||
| sbp | sd (mmHg) | 13 | 14 | 13 | 13 | ||||||
| uacr: more than 300 | n | 30 | |||||||||
| uacr: more than 300 | percent | 2.5 | |||||||||
| weight | mean (kg) | 87 | 86 | 86 | 87 | 85.09 | 86.56 | 89.48 | 88.84 | 81.94 | |
| weight | sd (kg) | 17 | 18 | 17 | 17 | 14.25 | 18.33 | 18.06 | 14.98 | 17.67 | |
| white | n | 157 | 162 | 158 | 91 | 7 | 13 | 4 | 9 | 12 | |
| white | percent | 52 | 54 | 50 | 51 |
Results
406 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (58 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.24 percent | -1.44 to -1.04 | 77 | not stated; modified itt; diabetes_duration:10_or_more; R0014882:Supplement Table 3 | |
| 26 | A1 | change | -0.94 percent | -1.07 to -0.82 | 203 | not stated; modified itt; hba1c:less_than_8.5; R0014882:Supplement Table 3 | |
| 26 | A1 | change | -1.22 percent | 0.05 | 301 | not stated; randomized; R0016652:Results | |
| 26 | A1 | change | -1.19 percent | -1.34 to -1.04 | 145 | not stated; modified itt; sex:male; R0014882:Supplement Table 3 | |
| 26 | A1 vs A4 | md | -1.26 percent | not stated; randomized; R0016652:Results | |||
| 26 | A1 | change | -1.80 percent | -1.98 to -1.62 | 98 | not stated; modified itt; hba1c:8.5_or_more; R0014882:Supplement Table 3 | |
| 26 | A1 vs A4 | md | -1.26 percent | -1.42 to -1.09 | not stated; randomized; registry:outcomes | ||
| 26 | A1 | change | -1.25 percent | -1.41 to -1.09 | 123 | not stated; modified itt; diabetes_duration:less_than_5; R0014882:Supplement Table 3 | |
| 26 | A1 | change | -1.25 percent | -1.39 to -1.10 | 156 | not stated; modified itt; sex:female; R0014882:Supplement Table 3 | |
| 26 | A1 | change | -1.17 percent | -1.35 to -0.99 | 101 | not stated; modified itt; diabetes_duration:5_to_less_than_10; R0014882:Supplement Table 3 | |
| 26 | A1 | change | -1.3 percent | 1.0 | 302 | not stated; other; R0008191:Supplement Table S3 | |
| 26 | A2 | change | -0.94 percent | -1.12 to -0.76 | 100 | not stated; modified itt; diabetes_duration:5_to_less_than_10; R0014882:Supplement Table 3 | |
| 26 | A2 | change | -0.97 percent | -1.16 to -0.78 | 91 | not stated; modified itt; diabetes_duration:10_or_more; R0014882:Supplement Table 3 | |
| 26 | A2 | change | -1.00 percent | -1.14 to -0.85 | 167 | not stated; modified itt; sex:female; R0014882:Supplement Table 3 | |
| 26 | A2 | change | -1.01 percent | 0.06 | 297 | not stated; randomized; R0016652:Results | |
| 26 | A2 vs A4 | md | -1.05 percent | not stated; randomized; R0016652:Results | |||
| 26 | A2 vs A4 | md | -1.05 percent | -1.21 to -0.88 | not stated; randomized; registry:outcomes | ||
| 26 | A2 | change | -1.03 percent | -1.19 to -0.87 | 130 | not stated; modified itt; sex:male; R0014882:Supplement Table 3 | |
| 26 | A2 | change | -1.47 percent | -1.66 to -1.29 | 94 | not stated; modified itt; hba1c:8.5_or_more; R0014882:Supplement Table 3 | |
| 26 | A2 | change | -1.10 percent | -1.28 to -0.92 | 106 | not stated; modified itt; diabetes_duration:less_than_5; R0014882:Supplement Table 3 | |
| 26 | A2 | change | -0.82 percent | -0.95 to -0.69 | 203 | not stated; modified itt; hba1c:less_than_8.5; R0014882:Supplement Table 3 | |
| 26 | A3 | change | -0.61 percent | -0.77 to -0.45 | not stated; modified itt; diabetes_duration:5_to_less_than_10; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.64 percent | -0.79 to -0.50 | not stated; modified itt; sex:male; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.61 percent | 0.05 | 311 | not stated; randomized; R0016652:Results | |
| 26 | A3 vs A4 | md | -0.64 percent | not stated; randomized; R0016652:Results | |||
| 26 | A3 vs A4 | md | -0.64 percent | -0.81 to -0.48 | not stated; randomized; registry:outcomes | ||
| 26 | A3 | change | -0.57 percent | -0.71 to -0.43 | not stated; modified itt; sex:female; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.49 percent | -0.61 to -0.36 | not stated; modified itt; hba1c:less_than_8.5; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.52 percent | -0.73 to -0.31 | not stated; modified itt; diabetes_duration:10_or_more; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.65 percent | -0.82 to -0.48 | not stated; modified itt; diabetes_duration:less_than_5; R0014882:Supplement Table 3 | ||
| 26 | A3 | change | -0.83 percent | -1.01 to -0.65 | not stated; modified itt; hba1c:8.5_or_more; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | 0.03 percent | 0.07 | 176 | not stated; randomized; R0016652:Results | |
| 26 | A4 | change | 0.07 percent | -0.12 to 0.26 | not stated; modified itt; sex:male; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | 0.41 percent | 0.12 to 0.69 | not stated; modified itt; diabetes_duration:10_or_more; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | 0.13 percent | -0.09 to 0.35 | not stated; modified itt; diabetes_duration:5_to_less_than_10; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.02 percent | -0.26 to 0.22 | not stated; modified itt; hba1c:8.5_or_more; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | -0.25 percent | -0.46 to -0.04 | not stated; modified itt; diabetes_duration:less_than_5; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | 0.00 percent | -0.20 to 0.19 | not stated; modified itt; sex:female; R0014882:Supplement Table 3 | ||
| 26 | A4 | change | 0.06 percent | -0.10 to 0.23 | not stated; modified itt; hba1c:less_than_8.5; R0014882:Supplement Table 3 | ||
| 27.4 | A1 | change | -1.49 percent | 1.12 | 20 | not stated; other; registry:outcomes | |
| 27.4 | A2 | change | -1.02 percent | 0.99 | 20 | not stated; other; registry:outcomes | |
| 27.4 | A3 | change | -0.76 percent | 0.86 | 30 | not stated; other; registry:outcomes | |
| 27.4 | A4 | change | -0.06 percent | 0.64 | 28 | not stated; other; registry:outcomes | |
| 27.4 | A5 | change | -1.09 percent | 0.77 | 10 | not stated; other; registry:outcomes | |
| 27.4 | A6 | change | -1.25 percent | 0.68 | 26 | not stated; other; registry:outcomes | |
| 27.4 | A7 | change | -0.98 percent | 0.47 | 8 | not stated; other; registry:outcomes | |
| 27.4 | A8 | change | -0.94 percent | 0.65 | 21 | not stated; other; registry:outcomes | |
| 27.4 | A9 | change | -0.70 percent | 0.49 | 14 | not stated; other; registry:outcomes | |
| 52 | A1 | change | -1.10 percent | 0.06 | 301 | not stated; randomized; R0016652:Results | |
| 52 | A1 vs A3 | md | -0.71 percent | -0.87 to -0.55 | not stated; randomized; R0016652:Results | ||
| 52 | A2 vs A3 | md | -0.47 percent | -0.63 to -0.31 | not stated; randomized; R0016652:Results | ||
| 52 | A2 | change | -0.87 percent | 0.06 | 297 | not stated; randomized; R0016652:Results | |
| 52 | A3 | change | -0.39 percent | 0.06 | 311 | not stated; randomized; R0016652:Results | |
| 104 | A1 vs A3 | md | -0.67 percent | -0.84 to -0.50 | not stated; randomized; R0025391:Results | ||
| 104 | A1 | change | -0.99 percent | 0.06 | 301 | not stated; randomized; R0025391:Results | |
| 104 | A2 | change | -0.71 percent | 0.07 | 297 | not stated; randomized; R0025391:Results | |
| 104 | A2 vs A3 | md | -0.39 percent | -0.56 to -0.22 | not stated; randomized; R0025391:Results | ||
| 104 | A3 | change | -0.32 percent | 0.06 | 311 | not stated; randomized; R0025391:Results |
Body weight change in kilograms (diabetes) (58 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -3.18 kg | 0.18 | 303 | not stated; randomized; registry:outcomes | |
| 26 | A1 vs A4 | md | -1.70 kg | -2.27 to -1.14 | not stated; randomized; registry:outcomes | ||
| 26 | A1 | change | -3.12 kg | -3.72 to -2.51 | 101 | not stated; modified itt; diabetes_duration:5_to_less_than_10; R0014882:Table 2 | |
| 26 | A1 | change | -3.77 kg | -4.26 to -3.27 | 156 | not stated; modified itt; sex:female; R0014882:Table 2 | |
| 26 | A1 | change | -3.03 kg | -3.59 to -2.48 | 123 | not stated; modified itt; diabetes_duration:less_than_5; R0014882:Table 2 | |
| 26 | A1 | change | -3.19 kg | -3.62 to -2.76 | 203 | not stated; modified itt; hba1c:less_than_8.5; R0014882:Table 2 | |
| 26 | A1 | change | -2.56 kg | -3.07 to -2.06 | 145 | not stated; modified itt; sex:male; R0014882:Table 2 | |
| 26 | A1 | change | -3.49 kg | -4.19 to -2.80 | 77 | not stated; modified itt; diabetes_duration:10_or_more; R0014882:Table 2 | |
| 26 | A1 | change | -3.17 kg | -3.79 to -2.56 | 98 | not stated; modified itt; hba1c:8.5_or_more; R0014882:Table 2 | |
| 26 | A1 | change | -3.3 kg | 3.3 | 271 | not stated; other; R0008191:Supplement Table S3 | |
| 26 | A2 | change | -2.44 kg | -3.07 to -1.82 | 94 | not stated; modified itt; hba1c:8.5_or_more; R0014882:Table 2 | |
| 26 | A2 | change | -2.81 kg | -3.42 to -2.21 | 106 | not stated; modified itt; diabetes_duration:less_than_5; R0014882:Table 2 | |
| 26 | A2 | change | -1.97 kg | -2.51 to -1.44 | 130 | not stated; modified itt; sex:male; R0014882:Table 2 | |
| 26 | A2 | change | -2.63 kg | 0.19 | 299 | not stated; randomized; registry:outcomes | |
| 26 | A2 vs A4 | md | -1.16 kg | -1.73 to -0.60 | not stated; randomized; registry:outcomes | ||
| 26 | A2 | change | -3.20 kg | -3.69 to -2.71 | 167 | not stated; modified itt; sex:female; R0014882:Table 2 | |
| 26 | A2 | change | -2.72 kg | -3.16 to -2.28 | 203 | not stated; modified itt; hba1c:less_than_8.5; R0014882:Table 2 | |
| 26 | A2 | change | -2.52 kg | -3.17 to -1.87 | 91 | not stated; modified itt; diabetes_duration:10_or_more; R0014882:Table 2 | |
| 26 | A2 | change | -2.53 kg | -3.13 to -1.92 | 100 | not stated; modified itt; diabetes_duration:5_to_less_than_10; R0014882:Table 2 | |
| 26 | A3 | change | -1.05 kg | -1.60 to -0.50 | not stated; modified itt; diabetes_duration:5_to_less_than_10; R0014882:Table 2 | ||
| 26 | A3 | change | -1.53 kg | -2.10 to -0.96 | not stated; modified itt; diabetes_duration:less_than_5; R0014882:Table 2 | ||
| 26 | A3 vs A4 | md | 0.02 kg | -0.54 to 0.58 | not stated; randomized; registry:outcomes | ||
| 26 | A3 | change | -1.46 kg | -1.88 to -1.03 | not stated; modified itt; hba1c:less_than_8.5; R0014882:Table 2 | ||
| 26 | A3 | change | -2.05 kg | -2.77 to -1.33 | not stated; modified itt; diabetes_duration:10_or_more; R0014882:Table 2 | ||
| 26 | A3 | change | -1.40 kg | -2.01 to -0.79 | not stated; modified itt; hba1c:8.5_or_more; R0014882:Table 2 | ||
| 26 | A3 | change | -1.15 kg | -1.65 to -0.65 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 26 | A3 | change | -1.46 kg | 0.18 | 314 | not stated; randomized; registry:outcomes | |
| 26 | A3 | change | -1.78 kg | -2.26 to -1.29 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26 | A4 | change | -1.31 kg | -1.95 to -0.67 | not stated; modified itt; sex:male; R0014882:Table 2 | ||
| 26 | A4 | change | -1.29 kg | -1.85 to -0.73 | not stated; modified itt; hba1c:less_than_8.5; R0014882:Table 2 | ||
| 26 | A4 | change | -1.87 kg | -2.68 to -1.06 | not stated; modified itt; hba1c:8.5_or_more; R0014882:Table 2 | ||
| 26 | A4 | change | -1.67 kg | -2.39 to -0.95 | not stated; modified itt; diabetes_duration:less_than_5; R0014882:Table 2 | ||
| 26 | A4 | change | -1.67 kg | -2.32 to -1.01 | not stated; modified itt; sex:female; R0014882:Table 2 | ||
| 26 | A4 | change | -1.35 kg | -2.09 to -0.61 | not stated; modified itt; diabetes_duration:5_to_less_than_10; R0014882:Table 2 | ||
| 26 | A4 | change | -1.23 kg | -2.19 to -0.27 | not stated; modified itt; diabetes_duration:10_or_more; R0014882:Table 2 | ||
| 26 | A4 | change | -1.47 kg | 0.24 | 177 | not stated; randomized; registry:outcomes | |
| 27.4 | A1 | change | -2.12 kg | 1.93 | 23 | not stated; other; registry:outcomes | |
| 27.4 | A2 | change | -1.17 kg | 2.30 | 20 | not stated; other; registry:outcomes | |
| 27.4 | A3 | change | -0.43 kg | 1.78 | 35 | not stated; other; registry:outcomes | |
| 27.4 | A4 | change | -0.56 kg | 1.69 | 33 | not stated; other; registry:outcomes | |
| 27.4 | A5 | change | -3.32 kg | 3.37 | 14 | not stated; other; registry:outcomes | |
| 27.4 | A6 | change | -2.15 kg | 1.97 | 30 | not stated; other; registry:outcomes | |
| 27.4 | A7 | change | -2.23 kg | 1.63 | 9 | not stated; other; registry:outcomes | |
| 27.4 | A8 | change | -1.53 kg | 1.88 | 22 | not stated; other; registry:outcomes | |
| 27.4 | A9 | change | -0.85 kg | 1.47 | 17 | not stated; other; registry:outcomes | |
| 52 | A1 vs A3 | md | -1.50 kg | -2.08 to -0.92 | not stated; randomized; registry:outcomes | ||
| 52 | A1 vs A3 | md | -1.50 kg | not stated; randomized; R0016652:Results | |||
| 52 | A1 | change | -3.03 kg | 0.22 | 303 | not stated; randomized; R0016652:Results | |
| 52 | A2 vs A3 | md | -1.07 kg | -1.65 to -0.48 | not stated; randomized; registry:outcomes | ||
| 52 | A2 vs A3 | md | -1.07 kg | not stated; randomized; R0016652:Results | |||
| 52 | A2 | change | -2.60 kg | 0.23 | 299 | not stated; randomized; R0016652:Results | |
| 52 | A3 | change | -1.53 kg | 0.22 | 314 | not stated; randomized; R0016652:Results | |
| 104 | A1 | change | -2.88 kg | 0.25 | 303 | not stated; randomized; R0025391:Results | |
| 104 | A1 vs A3 | md | -1.14 kg | -1.78 to -0.49 | not stated; randomized; registry:outcomes | ||
| 104 | A1 vs A3 | md | -1.14 kg | not stated; randomized; R0025391:Results | |||
| 104 | A2 vs A3 | md | -0.64 kg | -1.29 to 0.01 | not stated; randomized; registry:outcomes | ||
| 104 | A2 | change | -2.39 kg | 0.26 | 299 | not stated; randomized; R0025391:Results | |
| 104 | A3 | change | -1.75 kg | 0.25 | 314 | not stated; randomized; R0025391:Results |
HbA1c below 7 percent (13 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 vs A4 | or | 11.3 | 6.8 to 18.8 | not stated; randomized; registry:outcomes | ||
| 26 | A1 | responders | 61 | 302 | not stated; randomized; R0016652:Results | ||
| 26 | A2 | responders | 55 | 297 | not stated; randomized; R0016652:Results | ||
| 26 | A2 vs A4 | or | 8.6 | 5.2 to 14.3 | not stated; randomized; registry:outcomes | ||
| 26 | A3 vs A4 | or | 3.0 | 1.8 to 4.8 | not stated; randomized; registry:outcomes | ||
| 26 | A3 | responders | 38 | 312 | not stated; randomized; R0016652:Results | ||
| 26 | A4 | responders | 21 | 176 | not stated; randomized; R0016652:Results | ||
| 52 | A1 | responders | 58 | 302 | not stated; randomized; R0016652:Results | ||
| 52 | A2 | responders | 49 | 297 | not stated; randomized; R0016652:Results | ||
| 52 | A3 | responders | 33 | 312 | not stated; randomized; R0016652:Results | ||
| 104 | A1 | responders | 54.3 | 302 | not stated; randomized; R0025391:Figure 2C | ||
| 104 | A2 | responders | 44.8 | 297 | not stated; randomized; R0025391:Figure 2C | ||
| 104 | A3 | responders | 31.1 | 312 | not stated; randomized; R0025391:Figure 2C |
Level 2 or 3 hypoglycemia (participants) (46 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0.7 | 304 | not stated; modified itt; R0022281:Table 3 | |||
| A1 | events | 17 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 10.2 | 304 | not stated; randomized; R0016652:Results | |||
| A1 | events | 5 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 0 / 304 | not stated; randomized; R0025391:Results | ||||
| A1 | events | 5 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 7 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 0 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 12.8 | 304 | not stated; randomized; R0025391:Results | |||
| A1 | events | 6 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 14 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 9 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 33 / 304 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 5 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 0.7 | 302 | not stated; modified itt; R0022281:Table 3 | |||
| A2 | events | 0 / 302 | not stated; randomized; R0025391:Results | ||||
| A2 | events | 0 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 9 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 19 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 8 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 8.6 | 302 | not stated; randomized; R0025391:Results | |||
| A2 | events | 13 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 2 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 5 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 0 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 5.3 | 302 | not stated; randomized; R0016652:Results | |||
| A3 | events | 4.8 | 315 | not stated; randomized; R0016652:Results | |||
| A3 | events | 0 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 10 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 2 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 2 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 1.3 | 315 | not stated; modified itt; R0022281:Table 3 | |||
| A3 | events | 0 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 3 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 18 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 8.6 | 315 | not stated; randomized; R0025391:Results | |||
| A3 | events | 10 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 6 / 315 | not stated; randomized; registry:outcomes | ||||
| A3 | events | 0 / 315 | not stated; randomized; R0025391:Results | ||||
| A4 | events | 0 / 177 | not stated; randomized; registry:outcomes | ||||
| A4 | events | 0 / 177 | not stated; randomized; registry:outcomes | ||||
| A4 | events | 2 / 177 | not stated; randomized; registry:outcomes | ||||
| A4 | events | 0 / 177 | not stated; randomized; registry:outcomes | ||||
| A4 | events | 0 | 177 | not stated; modified itt; R0022281:Table 3 | |||
| A4 | events | 0 / 177 | not stated; randomized; registry:outcomes | ||||
| A4 | events | 1.1 | 177 | not stated; randomized; R0016652:Results |
Level 2 or 3 hypoglycemia (episode rate) (24 lines; O04B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | rate | 0.3 | not stated; randomized; R0025391:Results | ||||
| A1 | rate | 0.4 | not stated; randomized; R0016652:Results | ||||
| A1 | rate | 0.0 | not stated; randomized; R0025391:Supplement Table S3 | ||||
| A1 | rate | 0.0 | not stated; randomized; registry:outcomes | ||||
| A1 | rate | 0.0 | not stated; randomized; registry:outcomes | ||||
| A1 | rate | 0.2 | not stated; randomized; registry:outcomes | ||||
| A1 | rate | 0.3 | not stated; randomized; registry:outcomes | ||||
| A2 | rate | 0.1 | not stated; randomized; registry:outcomes | ||||
| A2 | rate | 0.0 | not stated; randomized; registry:outcomes | ||||
| A2 | rate | 0.3 | not stated; randomized; R0016652:Results | ||||
| A2 | rate | 0.2 | not stated; randomized; registry:outcomes | ||||
| A2 | rate | 0.0 | not stated; randomized; R0025391:Supplement Table S3 | ||||
| A2 | rate | 0.0 | not stated; randomized; registry:outcomes | ||||
| A2 | rate | 0.2 | not stated; randomized; R0025391:Results | ||||
| A3 | rate | 0.1 | not stated; randomized; registry:outcomes | ||||
| A3 | rate | 0.0 | not stated; randomized; registry:outcomes | ||||
| A3 | rate | 0.2 | not stated; randomized; R0025391:Results | ||||
| A3 | rate | 0.2 | not stated; randomized; registry:outcomes | ||||
| A3 | rate | 0.0 | not stated; randomized; R0025391:Supplement Table S3 | ||||
| A3 | rate | 0.1 | not stated; randomized; R0016652:Results | ||||
| A3 | rate | 0.0 | not stated; randomized; registry:outcomes | ||||
| A4 | rate | 0.0 | not stated; randomized; registry:outcomes | ||||
| A4 | rate | 0.1 | not stated; randomized; R0016652:Results | ||||
| A4 | rate | 0.1 | not stated; randomized; registry:outcomes |
Systolic blood pressure change (21 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.7 mmHg | 0.7 | 271 | not stated; randomized; R0016652:Table 2 | |
| 26 | A1 | change | -2.4 mmHg | 11.3 | 271 | not stated; other; R0008191:Supplement Table S3 | |
| 26 | A1 vs A4 | md | -2.5 mmHg | -4.9 to -0.1 | not stated; other; R0008191:Supplement Table S4 | ||
| 26 | A2 | change | -1.4 mmHg | 0.7 | 278 | not stated; randomized; R0016652:Table 2 | |
| 26 | A3 | change | -1.9 mmHg | 0.7 | 283 | not stated; randomized; R0016652:Table 2 | |
| 26 | A4 | change | 1.1 mmHg | 0.9 | 138 | not stated; randomized; R0016652:Table 2 | |
| 27.4 | A1 | change | -4.77 mmHg | 11.37 | 23 | not stated; other; registry:outcomes | |
| 27.4 | A2 | change | -6.21 mmHg | 19.13 | 20 | not stated; other; registry:outcomes | |
| 27.4 | A3 | change | -2.16 mmHg | 10.62 | 35 | not stated; other; registry:outcomes | |
| 27.4 | A4 | change | -0.61 mmHg | 14.75 | 33 | not stated; other; registry:outcomes | |
| 27.4 | A5 | change | -8.85 mmHg | 12.92 | 14 | not stated; other; registry:outcomes | |
| 27.4 | A6 | change | -4.63 mmHg | 15.28 | 30 | not stated; other; registry:outcomes | |
| 27.4 | A7 | change | -2.00 mmHg | 9.94 | 9 | not stated; other; registry:outcomes | |
| 27.4 | A8 | change | 0.40 mmHg | 11.51 | 22 | not stated; other; registry:outcomes | |
| 27.4 | A9 | change | 1.67 mmHg | 10.18 | 17 | not stated; other; registry:outcomes | |
| 52 | A1 | change | -0.8 mmHg | 0.7 | not stated; randomized; R0016652:Table 2 | ||
| 52 | A2 | change | -0.5 mmHg | 0.7 | not stated; randomized; R0016652:Table 2 | ||
| 52 | A3 | change | -0.5 mmHg | 0.7 | not stated; randomized; R0016652:Table 2 | ||
| 104 | A1 | change | -0.1 mmHg | 0.8 | 197 | not stated; randomized; R0025391:Table 1 | |
| 104 | A2 | change | 1.3 mmHg | 0.8 | 192 | not stated; randomized; R0025391:Table 1 | |
| 104 | A3 | change | 0.02 mmHg | 0.82 | 191 | not stated; randomized; registry:outcomes |
Weight loss of 10 percent or more (4 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 6.0 | 304 | not stated; modified itt; R0025019:Supplement Table S1 | ||
| 26 | A2 | responders | 4.4 | 302 | not stated; modified itt; R0025019:Supplement Table S1 | ||
| 26 | A3 | responders | 1.9 | 315 | not stated; modified itt; R0025019:Supplement Table S1 | ||
| 26 | A4 | responders | 1.1 | 177 | not stated; modified itt; R0025019:Supplement Table S1 |
Acute kidney injury (1 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A3 | events | 0 / 315 | not stated; randomized; R0025391:Table 1 |
All cause mortality (12 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A1 | events | 1 / 304 | not stated; randomized; R0025391:Table 1 | ||||
| A1 | events | 1 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 0 / 302 | not stated; randomized; R0025391:Table 1 | ||||
| A2 | events | 0 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 0 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 2 / 315 | not stated; randomized; R0025391:Table 1 | ||||
| A3 | events | 0 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 2 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A4 | events | 0 / 177 | not stated; randomized; R0016652:Table 2 | ||||
| A7 | events | 0 / 10 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; registry:adverse_events |
Hospitalization for heart failure (2 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A7 | events | 0 / 10 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; registry:adverse_events |
Health related quality of life total score (any instrument) (12 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | final | 86.92 points | 14.972 | 237 | not stated; randomized; registry:outcomes | |
| 52 | A1 | final | 0.83 points | 0.211 | 237 | not stated; randomized; registry:outcomes | |
| 52 | A2 | final | 0.84 points | 0.208 | 250 | not stated; randomized; registry:outcomes | |
| 52 | A2 | final | 86.31 points | 14.673 | 252 | not stated; randomized; registry:outcomes | |
| 52 | A3 | final | 86.25 points | 15.628 | 247 | not stated; randomized; registry:outcomes | |
| 52 | A3 | final | 0.85 points | 0.210 | 244 | not stated; randomized; registry:outcomes | |
| 104 | A1 | final | 88.08 points | 15.555 | 190 | not stated; randomized; registry:outcomes | |
| 104 | A1 | final | 0.84 points | 0.203 | 189 | not stated; randomized; registry:outcomes | |
| 104 | A2 | final | 87.47 points | 15.183 | 190 | not stated; randomized; registry:outcomes | |
| 104 | A2 | final | 0.86 points | 0.184 | 190 | not stated; randomized; registry:outcomes | |
| 104 | A3 | final | 0.86 points | 0.198 | 185 | not stated; randomized; registry:outcomes | |
| 104 | A3 | final | 86.93 points | 16.304 | 185 | not stated; randomized; registry:outcomes |
Serious adverse events (15 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 17 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A1 | events | 36 / 304 | not stated; randomized; R0025391:Table 1 | ||||
| A1 | events | 26 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 10 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 16 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 23 / 302 | not stated; randomized; R0025391:Table 1 | ||||
| A3 | events | 17 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 11 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 32 / 315 | not stated; randomized; R0025391:Table 1 | ||||
| A4 | events | 6 / 177 | not stated; randomized; R0016652:Table 2 | ||||
| A5 | events | 1 / 15 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 1 / 30 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 10 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 1 / 25 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (15 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 33 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A1 | events | 63 / 304 | not stated; randomized; R0025391:Table 1 | ||||
| A1 | events | 21 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 23 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 64 / 302 | not stated; randomized; R0025391:Table 1 | ||||
| A2 | events | 12 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 65 / 315 | not stated; randomized; R0025391:Table 1 | ||||
| A3 | events | 14 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 30 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A4 | events | 24 / 177 | not stated; randomized; R0016652:Table 2 | ||||
| A5 | events | 4 / 15 | not stated; randomized; registry:flow | ||||
| A6 | events | 4 / 30 | not stated; randomized; registry:flow | ||||
| A7 | events | 1 / 10 | not stated; randomized; registry:flow | ||||
| A8 | events | 0 / 25 | not stated; randomized; registry:flow | ||||
| A9 | events | 1 / 24 | not stated; randomized; registry:flow |
Nausea (16 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 51 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A1 | events | 53 / 304 | not stated; randomized; R0025391:Table 1 | ||||
| A1 | events | 53 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 38 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 44 / 302 | not stated; randomized; R0025391:Table 1 | ||||
| A2 | events | 42 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 14 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 22 / 315 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 16 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 21 / 315 | not stated; randomized; R0025391:Table 1 | ||||
| A4 | events | 7 / 177 | not stated; randomized; R0016652:Table 2 | ||||
| A5 | events | 5 / 15 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 6 / 30 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 4 / 10 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 3 / 25 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 2 / 24 | not stated; safety; registry:adverse_events |
Vomiting (15 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 36 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A1 | events | 41 / 304 | not stated; randomized; R0025391:Table 1 | ||||
| A1 | events | 39 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 23 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 25 / 302 | not stated; randomized; R0025391:Table 1 | ||||
| A2 | events | 22 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 6 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 7 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 11 / 315 | not stated; randomized; R0025391:Table 1 | ||||
| A4 | events | 1 / 177 | not stated; randomized; R0016652:Table 2 | ||||
| A5 | events | 2 / 15 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 4 / 30 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 2 / 10 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 1 / 25 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 1 / 24 | not stated; safety; registry:adverse_events |
Diarrhea (16 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 44 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A1 | events | 49 / 304 | not stated; randomized; R0025391:Table 1 | ||||
| A1 | events | 50 / 304 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 39 / 304 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 30 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 27 / 302 | not stated; randomized; R0016652:Table 2 | ||||
| A2 | events | 36 / 302 | not stated; randomized; R0025391:Table 1 | ||||
| A3 | events | 8 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A3 | events | 18 / 315 | not stated; randomized; R0025391:Table 1 | ||||
| A3 | events | 9 / 315 | not stated; randomized; R0016652:Table 2 | ||||
| A4 | events | 11 / 177 | not stated; randomized; R0016652:Table 2 | ||||
| A5 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 5 / 30 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 1 / 10 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 4 / 25 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 2 / 24 | not stated; safety; registry:adverse_events |
Constipation (8 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 14 / 304 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 16 / 302 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 4 / 315 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 1 / 15 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 30 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 10 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 3 / 25 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; registry:adverse_events |
Discontinuation due to gastrointestinal adverse events (8 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 304 | not stated; randomized; nausea; R0025391:Results | ||||
| A1 | events | 8 / 304 | not stated; randomized; nausea; R0016652:Results | ||||
| A2 | events | 3 / 302 | not stated; randomized; nausea; R0025391:Results | ||||
| A2 | events | 3 / 302 | not stated; randomized; nausea; R0016652:Results | ||||
| A3 | events | 0 / 315 | not stated; randomized; nausea; R0016652:Results | ||||
| A3 | events | 0 / 315 | not stated; randomized; nausea; R0025391:Results | ||||
| A3 | events | 0 / 315 | not stated; randomized; nausea; R0016652:Results | ||||
| A4 | events | 0 / 177 | not stated; randomized; nausea; R0016652:Results |
Gallbladder and biliary disease (8 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 304 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 1 / 302 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 315 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A5 | events | 0 / 15 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A6 | events | 0 / 30 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A7 | events | 0 / 10 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A8 | events | 0 / 25 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; cholelithiasis; registry:adverse_events |
Acute pancreatitis (25 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 304 | not stated; randomized; registry:outcomes | ||||
| A1 | events | 0 / 304 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A1 | events | 0 / 304 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A2 | events | 0 / 302 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 302 | not stated; randomized; registry:outcomes | ||||
| A2 | events | 0 / 302 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A3 | events | 0 / 315 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A3 | events | 1 / 315 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A3 | events | 2 / 315 | not stated; randomized; registry:outcomes | ||||
| A4 | events | 0 / 177 | not stated; randomized; registry:outcomes | ||||
| A5 | events | 0 / 15 | not stated; randomized; registry:outcomes | ||||
| A5 | events | 0 / 15 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A5 | events | 0 / 15 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A6 | events | 0 / 30 | not stated; randomized; registry:outcomes | ||||
| A6 | events | 0 / 30 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A6 | events | 0 / 30 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A7 | events | 0 / 10 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A7 | events | 0 / 10 | not stated; randomized; registry:outcomes | ||||
| A7 | events | 0 / 10 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A8 | events | 0 / 25 | not stated; randomized; registry:outcomes | ||||
| A8 | events | 0 / 25 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A8 | events | 0 / 25 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; randomized; registry:outcomes | ||||
| A9 | events | 0 / 24 | not stated; safety; pancreatitis acute; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; pancreatitis; registry:adverse_events |
Medullary thyroid carcinoma (3 lines; O32A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 304 | not stated; safety; R0016652:Results | ||||
| A2 | events | 0 / 302 | not stated; safety; R0016652:Results | ||||
| A3 | events | 0 / 315 | not stated; safety; R0016652:Results |
Thyroid cancer (any) (12 lines; O32B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 304 | not stated; safety; R0025391:Results | ||||
| A1 | events | 1 / 304 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 304 | not stated; safety; R0016652:Results | ||||
| A2 | events | 0 / 302 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 302 | not stated; safety; R0016652:Results | ||||
| A3 | events | 0 / 315 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 315 | not stated; safety; R0016652:Results | ||||
| A5 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 1 / 30 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 10 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 25 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; registry:adverse_events |
Death by suicide (6 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 304 | not stated; randomized; R0025391:Results | ||||
| A2 | events | 0 / 302 | not stated; randomized; R0025391:Table 1 | ||||
| A3 | events | 0 / 315 | not stated; randomized; R0025391:Results | ||||
| A4 | events | 0 / 177 | not stated; randomized; R0016652:Table 2 | ||||
| A7 | events | 0 / 10 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; registry:adverse_events |
Intestinal obstruction or ileus (8 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 304 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 302 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 315 | not stated; safety; registry:adverse_events | ||||
| A5 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A6 | events | 0 / 30 | not stated; safety; registry:adverse_events | ||||
| A7 | events | 0 / 10 | not stated; safety; registry:adverse_events | ||||
| A8 | events | 0 / 25 | not stated; safety; registry:adverse_events | ||||
| A9 | events | 0 / 24 | not stated; safety; registry:adverse_events |