parallel randomized trial
NCT02229396
A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide extended release and dapagliflozin 2 to 10 mg injection once weekly Exenatide once weekly plus dapagliflozin | metformin; lifestyle: not reported | 231 | 228 | |
| A2 | Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly plus placebo | metformin; lifestyle: not reported | 231 | 227 | |
| A3 | Dapagliflozin Dapagliflozin plus placebo | metformin; lifestyle: not reported | 233 | 230 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Exenatide extended release and dapagliflozin 2 to 10 mg injection once weekly A1 | Exenatide extended release 2 mg subcutaneous once weekly A2 | Dapagliflozin A3 |
|---|---|---|---|---|
| age | mean (years) | 53.8 | 54.2 | 54.5 |
| age | sd (years) | 9.8 | 9.6 | 9.2 |
| asian | n | 3 | 1 | 1 |
| black | n | 34 | 27 | 33 |
| bmi | mean (kg/m2) | 33.2 | 32.0 | 33.0 |
| bmi | sd (kg/m2) | 6.8 | 5.9 | 6.1 |
| diabetes duration | mean (years) | 7.6 | 7.4 | 7.1 |
| diabetes duration | sd (years) | 6.0 | 5.5 | 5.5 |
| egfr: 60 to less than 90 | n | 76 | 73 | 69 |
| egfr: 90 or more | n | 112 | 105 | 117 |
| egfr: less than 60 | n | 6 | 6 | 10 |
| female | n | 126 | 111 | 120 |
| female | percent | 55 | 49 | 52 |
| hba1c | mean (percent) | 9.3 | 9.3 | 9.3 |
| hba1c | sd (percent) | 1.1 | 1.1 | 1.0 |
| other race american indian alaska native | n | 0 | 2 | 0 |
| other race other | n | 1 | 3 | 7 |
| sbp | mean (mmHg) | 130.1 | 129.1 | 130.0 |
| sbp | sd (mmHg) | 12.7 | 13.1 | 12.9 |
| waist | mean (cm) | 108.7 | 107.1 | 109.0 |
| waist | sd (cm) | 16.6 | 16.2 | 15.6 |
| weight | mean (kg) | 91.8 | 89.8 | 91.1 |
| weight | sd (kg) | 22.2 | 20.2 | 19.7 |
| white | n | 190 | 194 | 189 |
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); 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
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- 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
- 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 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
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); descriptive only
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); descriptive only
- 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
Results
213 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (78 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 28 | A1 vs A2 | md | -0.38 percent | -0.63 to -0.13 | hypothetical; modified itt; R0026313:Table 3 | ||
| 28 | A1 vs A3 | md | -0.59 percent | -0.84 to -0.34 | hypothetical; modified itt; R0026313:Table 3 | ||
| 28 | A1 | change | -1.98 percent | -2.16 to -1.79 | 228 | hypothetical; modified itt; R0026313:Table 3 | |
| 28 | A1 vs A2 | md | -0.38 percent | 0.129 | -0.63 to -0.13 | not stated; modified itt; registry:outcomes | |
| 28 | A1 vs A3 | md | -0.59 percent | 0.127 | -0.84 to -0.34 | not stated; modified itt; registry:outcomes | |
| 28 | A1 | change | -2.39 percent | not stated; other; age:65_or_older; R0024661:Abstract | |||
| 28 | A1 | change | -20.9 mmol/mol | not stated; other; age:less_than_65; R0024661:Figure 1A | |||
| 28 | A1 | change | -20.6 mmol/mol | 1.7 | 63 | not stated; other; bmi:25_to_less_than_30; R0024661:Table 1 | |
| 28 | A1 | change | -22.1 mmol/mol | 1.3 | 117 | not stated; other; bmi:30_or_more; R0024661:Table 1 | |
| 28 | A1 | change | -23.1 mmol/mol | 3.7 | 13 | not stated; other; bmi:less_than_25; R0024661:Table 1 | |
| 28 | A1 | change | -20.3 mmol/mol | 1.4 | 100 | not stated; other; diabetes_duration:3_to_10; R0024661:Table 1 | |
| 28 | A1 | change | -24.4 mmol/mol | 2.2 | 42 | not stated; other; diabetes_duration:less_than_3; R0024661:Table 1 | |
| 28 | A1 | change | -21.5 mmol/mol | 2.0 | 51 | not stated; other; diabetes_duration:more_than_10; R0024661:Table 1 | |
| 28 | A1 | change | -1.74 percent | not stated; other; egfr:60_to_less_than_90; R0024661:Abstract | |||
| 28 | A1 | change | -2.16 percent | not stated; other; egfr:90_or_more; R0024661:Abstract | |||
| 28 | A1 | change | -17.2 mmol/mol | not stated; other; egfr:less_than_60; R0024661:Figure 1B | |||
| 28 | A1 | change | -17.9 mmol/mol | 1.6 | 76 | not stated; other; ethnicity:hispanic_latino; R0024661:Table 1 | |
| 28 | A1 | change | -23.5 mmol/mol | 1.3 | 117 | not stated; other; ethnicity:not_hispanic_latino; R0024661:Table 1 | |
| 28 | A1 | change | -18.0 mmol/mol | 1.6 | 74 | not stated; other; hba1c:8.0_to_less_than_9.0; R0024661:Table 1 | |
| 28 | A1 | change | -24.7 mmol/mol | 1.3 | 108 | not stated; other; hba1c:9.0_or_more; R0024661:Table 1 | |
| 28 | A1 | change | -16.7 mmol/mol | 4.2 | 11 | not stated; other; hba1c:less_than_8.0; R0024661:Table 1 | |
| 28 | A1 | change | -8.4 mmol/mol | 8.3 | 3 | not stated; other; race:asian; R0024661:Table 1 | |
| 28 | A1 | change | -23.6 mmol/mol | 2.6 | 28 | not stated; other; race:black; R0024661:Table 1 | |
| 28 | A1 | change | -19.1 mmol/mol | 14.4 | 1 | not stated; other; race:other; R0024661:Table 1 | |
| 28 | A1 | change | -21.3 mmol/mol | 1.2 | 161 | not stated; other; race:white; R0024661:Table 1 | |
| 28 | A1 | change | -22.2 mmol/mol | 1.3 | 109 | not stated; other; sex:female; R0024661:Table 1 | |
| 28 | A1 | change | -21.0 mmol/mol | 1.5 | 84 | not stated; other; sex:male; R0024661:Table 1 | |
| 28 | A2 | change | -17.7 mmol/mol | 1.4 | 96 | not stated; other; sex:male; R0024661:Table 1 | |
| 28 | A2 | change | -16.9 mmol/mol | 1.4 | 101 | not stated; other; diabetes_duration:3_to_10; R0024661:Table 1 | |
| 28 | A2 | change | -17.7 mmol/mol | 14.4 | 1 | not stated; other; race:asian; R0024661:Table 1 | |
| 28 | A2 | change | -20.6 mmol/mol | 2.2 | 42 | not stated; other; diabetes_duration:less_than_3; R0024661:Table 1 | |
| 28 | A2 | change | -16.0 mmol/mol | 2.1 | 41 | not stated; other; diabetes_duration:more_than_10; R0024661:Table 1 | |
| 28 | A2 | change | -17.4 mmol/mol | 1.4 | 88 | not stated; other; sex:female; R0024661:Table 1 | |
| 28 | A2 | change | -1.55 percent | not stated; other; egfr:60_to_less_than_90; R0024661:Abstract | |||
| 28 | A2 | change | -18.8 mmol/mol | 3.0 | 20 | not stated; other; race:black; R0024661:Table 1 | |
| 28 | A2 | change | -1.62 percent | not stated; other; egfr:90_or_more; R0024661:Abstract | |||
| 28 | A2 | change | -21.3 mmol/mol | not stated; other; egfr:less_than_60; R0024661:Figure 1B | |||
| 28 | A2 | change | -14.8 mmol/mol | 1.7 | 68 | not stated; other; ethnicity:hispanic_latino; R0024661:Table 1 | |
| 28 | A2 | change | -18.7 mmol/mol | 1.3 | 116 | not stated; other; ethnicity:not_hispanic_latino; R0024661:Table 1 | |
| 28 | A2 | change | -13.7 mmol/mol | 1.6 | 71 | not stated; other; hba1c:8.0_to_less_than_9.0; R0024661:Table 1 | |
| 28 | A2 | change | -1.60 percent | -1.79 to -1.41 | 227 | hypothetical; modified itt; R0026313:Table 3 | |
| 28 | A2 | change | -17.3 mmol/mol | 1.2 | 161 | not stated; other; race:white; R0024661:Table 1 | |
| 28 | A2 | change | -21.4 mmol/mol | 1.3 | 100 | not stated; other; hba1c:9.0_or_more; R0024661:Table 1 | |
| 28 | A2 | change | -13.7 mmol/mol | not stated; other; age:65_or_older; R0024661:Figure 1A | |||
| 28 | A2 | change | -18.0 mmol/mol | not stated; other; age:less_than_65; R0024661:Figure 1A | |||
| 28 | A2 | change | -7.5 mmol/mol | 3.9 | 13 | not stated; other; hba1c:less_than_8.0; R0024661:Table 1 | |
| 28 | A2 | change | -16.5 mmol/mol | 1.7 | 65 | not stated; other; bmi:25_to_less_than_30; R0024661:Table 1 | |
| 28 | A2 | change | -17.8 mmol/mol | 1.3 | 107 | not stated; other; bmi:30_or_more; R0024661:Table 1 | |
| 28 | A2 | change | -9.1 mmol/mol | 10.2 | 2 | not stated; other; race:american_indian_alaska_native; R0024661:Table 1 | |
| 28 | A2 | change | -20.4 mmol/mol | 3.8 | 12 | not stated; other; bmi:less_than_25; R0024661:Table 1 | |
| 28 | A3 | change | -15.0 mmol/mol | 1.2 | 124 | not stated; other; ethnicity:not_hispanic_latino; R0024661:Table 1 | |
| 28 | A3 | change | -15.8 mmol/mol | 1.4 | 93 | not stated; other; sex:male; R0024661:Table 1 | |
| 28 | A3 | change | -10.8 mmol/mol | 3.8 | 14 | not stated; other; hba1c:less_than_8.0; R0024661:Table 1 | |
| 28 | A3 | change | -10.7 mmol/mol | 1.6 | 76 | not stated; other; hba1c:8.0_to_less_than_9.0; R0024661:Table 1 | |
| 28 | A3 | change | -16.0 mmol/mol | not stated; other; age:less_than_65; R0024661:Figure 1A | |||
| 28 | A3 | change | -1.39 percent | -1.57 to -1.21 | 230 | hypothetical; modified itt; R0026313:Table 3 | |
| 28 | A3 | change | -20.1 mmol/mol | 3.9 | 12 | not stated; other; bmi:less_than_25; R0024661:Table 1 | |
| 28 | A3 | change | -14.4 mmol/mol | 1.3 | 110 | not stated; other; diabetes_duration:3_to_10; R0024661:Table 1 | |
| 28 | A3 | change | -15.1 mmol/mol | 1.2 | 135 | not stated; other; bmi:30_or_more; R0024661:Table 1 | |
| 28 | A3 | change | -14.6 mmol/mol | 1.4 | 103 | not stated; other; sex:female; R0024661:Table 1 | |
| 28 | A3 | change | -9.0 mmol/mol | not stated; other; age:65_or_older; R0024661:Figure 1A | |||
| 28 | A3 | change | -14.6 mmol/mol | 1.7 | 72 | not stated; other; ethnicity:hispanic_latino; R0024661:Table 1 | |
| 28 | A3 | change | -24.8 mmol/mol | 5.9 | 6 | not stated; other; race:other; R0024661:Table 1 | |
| 28 | A3 | change | -15.0 mmol/mol | 1.2 | 165 | not stated; other; race:white; R0024661:Table 1 | |
| 28 | A3 | change | -19.5 mmol/mol | 2.1 | 40 | not stated; other; diabetes_duration:less_than_3; R0024661:Table 1 | |
| 28 | A3 | change | -15.3 mmol/mol | 14.4 | 1 | not stated; other; race:asian; R0024661:Table 1 | |
| 28 | A3 | change | -12.4 mmol/mol | 2.1 | 46 | not stated; other; diabetes_duration:more_than_10; R0024661:Table 1 | |
| 28 | A3 | change | -1.10 percent | not stated; other; egfr:60_to_less_than_90; R0024661:Abstract | |||
| 28 | A3 | change | -19.0 mmol/mol | 1.3 | 106 | not stated; other; hba1c:9.0_or_more; R0024661:Table 1 | |
| 28 | A3 | change | -1.58 percent | not stated; other; egfr:90_or_more; R0024661:Abstract | |||
| 28 | A3 | change | -13.0 mmol/mol | 2.6 | 24 | not stated; other; race:black; R0024661:Table 1 | |
| 28 | A3 | change | -14.1 mmol/mol | 2.0 | 49 | not stated; other; bmi:25_to_less_than_30; R0024661:Table 1 | |
| 28 | A3 | change | -11.8 mmol/mol | not stated; other; egfr:less_than_60; R0024661:Figure 1B | |||
| 52 | A1 | change | -1.75 percent | -1.94 to -1.56 | not stated; modified itt; R0026313:Table 3 | ||
| 52 | A1 vs A3 | md | -0.52 percent | -0.79 to -0.26 | not stated; modified itt; R0026313:Table 3 | ||
| 52 | A1 vs A2 | md | -0.37 percent | -0.64 to -0.11 | not stated; modified itt; R0026313:Table 3 | ||
| 52 | A2 | change | -1.38 percent | -1.57 to -1.18 | not stated; modified itt; R0026313:Table 3 | ||
| 52 | A3 | change | -1.23 percent | -1.42 to -1.04 | not stated; modified itt; R0026313:Table 3 |
Body weight change in kilograms (diabetes) (78 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 28 | A1 vs A2 | md | -2.00 kg | -2.79 to -1.20 | hypothetical; modified itt; R0026313:Table 3 | ||
| 28 | A1 | change | -3.55 kg | 0.29 | 228 | hypothetical; modified itt; R0024738:Results | |
| 28 | A1 | change | -3.55 kg | -4.12 to -2.99 | 228 | hypothetical; modified itt; R0026313:Table 3 | |
| 28 | A1 vs A3 | md | -1.33 kg | -2.12 to -0.55 | hypothetical; modified itt; R0026313:Table 3 | ||
| 28 | A1 vs A2 | md | -2.00 kg | 0.406 | -2.79 to -1.20 | not stated; modified itt; registry:outcomes | |
| 28 | A1 vs A3 | md | -1.33 kg | 0.400 | -2.12 to -0.55 | not stated; modified itt; registry:outcomes | |
| 28 | A1 | change | -3.29 kg | 0.76 | 29 | not stated; other; age:65_or_older; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.59 kg | 0.31 | 165 | not stated; other; age:less_than_65; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -2.75 kg | 63 | hypothetical; modified itt; bmi:25_to_less_than_30; R0024738:Figure 1A | ||
| 28 | A1 | change | -4.15 kg | 117 | hypothetical; modified itt; bmi:30_or_more; R0024738:Figure 1A | ||
| 28 | A1 | change | -2.11 kg | 14 | hypothetical; modified itt; bmi:less_than_25; R0024738:Figure 1A | ||
| 28 | A1 | change | -3.04 kg | 0.40 | 101 | not stated; other; diabetes_duration:3_to_10; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -4.55 kg | 0.61 | 42 | not stated; other; diabetes_duration:less_than_3; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.77 kg | 0.56 | 51 | not stated; other; diabetes_duration:more_than_10; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.67 kg | 0.46 | 76 | not stated; other; egfr:60_to_less_than_90; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.49 kg | 0.38 | 112 | not stated; other; egfr:90_or_more; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.42 kg | 1.67 | 6 | not stated; other; egfr:less_than_60; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -2.07 kg | 0.46 | 76 | not stated; other; ethnicity:hispanic_latino; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -4.47 kg | 0.36 | 118 | not stated; other; ethnicity:not_hispanic_latino; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -4.33 kg | 0.47 | 74 | not stated; other; hba1c:8.0_to_less_than_9.0; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.04 kg | 0.38 | 109 | not stated; other; hba1c:9.0_or_more; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.79 kg | 1.20 | 11 | not stated; other; hba1c:less_than_8.0; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.23 kg | 0.75 | 29 | not stated; other; race:black; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.49 kg | 2.10 | 4 | not stated; other; race:other; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.54 kg | 0.32 | 161 | not stated; other; race:white; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -3.98 kg | 0.38 | 109 | not stated; other; sex:female; R0024661:Supplement Table S1 | |
| 28 | A1 | change | -2.99 kg | 0.43 | 85 | not stated; other; sex:male; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -0.87 kg | 65 | hypothetical; modified itt; bmi:25_to_less_than_30; R0024738:Figure 1A | ||
| 28 | A2 | change | 0.39 kg | 12 | hypothetical; modified itt; bmi:less_than_25; R0024738:Figure 1A | ||
| 28 | A2 | change | -1.25 kg | 0.39 | 101 | not stated; other; diabetes_duration:3_to_10; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -2.19 kg | 107 | hypothetical; modified itt; bmi:30_or_more; R0024738:Figure 1A | ||
| 28 | A2 | change | -2.11 kg | 0.62 | 42 | not stated; other; diabetes_duration:less_than_3; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.77 kg | 0.59 | 41 | not stated; other; diabetes_duration:more_than_10; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -0.56 kg | 0.40 | 96 | not stated; other; sex:male; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -2.05 kg | 0.47 | 73 | not stated; other; egfr:60_to_less_than_90; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.20 kg | 0.38 | 105 | not stated; other; egfr:90_or_more; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.57 kg | 0.31 | 160 | not stated; other; age:less_than_65; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -2.56 kg | 1.59 | 6 | not stated; other; egfr:less_than_60; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -0.77 kg | 0.47 | 68 | not stated; other; ethnicity:hispanic_latino; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.41 kg | 0.81 | 24 | not stated; other; age:65_or_older; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.97 kg | 0.36 | 116 | not stated; other; ethnicity:not_hispanic_latino; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.74 kg | 0.47 | 71 | not stated; other; hba1c:8.0_to_less_than_9.0; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.45 kg | 0.39 | 100 | not stated; other; hba1c:9.0_or_more; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.90 kg | 1.14 | 13 | not stated; other; hba1c:less_than_8.0; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.03 kg | 0.85 | 20 | not stated; other; race:black; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -0.20 kg | 2.01 | 3 | not stated; other; race:other; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.56 kg | -2.13 to -0.98 | 227 | hypothetical; modified itt; R0026313:Table 3 | |
| 28 | A2 | change | -1.59 kg | 0.32 | 161 | not stated; other; race:white; R0024661:Supplement Table S1 | |
| 28 | A2 | change | -1.56 kg | 0.29 | 227 | hypothetical; modified itt; R0024738:Results | |
| 28 | A2 | change | -2.63 kg | 0.41 | 88 | not stated; other; sex:female; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -1.83 kg | 0.41 | 93 | not stated; other; sex:male; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.64 kg | 0.77 | 24 | not stated; other; race:black; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.22 kg | 0.28 | 230 | hypothetical; modified itt; R0024738:Results | |
| 28 | A3 | change | -2.89 kg | 0.35 | 124 | not stated; other; ethnicity:not_hispanic_latino; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -3.55 kg | 1.24 | 10 | not stated; other; egfr:less_than_60; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -3.33 kg | 0.85 | 21 | not stated; other; age:65_or_older; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -0.94 kg | 0.47 | 72 | not stated; other; ethnicity:hispanic_latino; R0024661:Supplement Table S1 | |
| 28 | A3 | change | 1.80 kg | 12 | hypothetical; modified itt; bmi:less_than_25; R0024738:Figure 1A | ||
| 28 | A3 | change | -2.88 kg | 135 | hypothetical; modified itt; bmi:30_or_more; R0024738:Figure 1A | ||
| 28 | A3 | change | -2.09 kg | 0.32 | 165 | not stated; other; race:white; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.58 kg | 0.38 | 110 | not stated; other; diabetes_duration:3_to_10; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.02 kg | 0.46 | 76 | not stated; other; hba1c:8.0_to_less_than_9.0; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.09 kg | 0.61 | 40 | not stated; other; diabetes_duration:less_than_3; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -1.43 kg | 49 | hypothetical; modified itt; bmi:25_to_less_than_30; R0024738:Figure 1A | ||
| 28 | A3 | change | -2.09 kg | 1.55 | 7 | not stated; other; race:other; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -1.48 kg | 0.58 | 46 | not stated; other; diabetes_duration:more_than_10; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.26 kg | 0.38 | 106 | not stated; other; hba1c:9.0_or_more; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.85 kg | 0.48 | 69 | not stated; other; egfr:60_to_less_than_90; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.08 kg | 0.30 | 175 | not stated; other; age:less_than_65; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.56 kg | 0.39 | 103 | not stated; other; sex:female; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -1.75 kg | 0.37 | 117 | not stated; other; egfr:90_or_more; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -3.40 kg | 1.09 | 14 | not stated; other; hba1c:less_than_8.0; R0024661:Supplement Table S1 | |
| 28 | A3 | change | -2.22 kg | -2.78 to -1.66 | 230 | hypothetical; modified itt; R0026313:Table 3 | |
| 52 | A1 vs A3 | md | -1.02 kg | -2.08 to 0.03 | not stated; modified itt; R0026313:Table 3 | ||
| 52 | A1 | change | -3.31 kg | -4.05 to -2.57 | not stated; modified itt; R0026313:Table 3 | ||
| 52 | A1 vs A2 | md | -1.80 kg | -2.87 to -0.73 | not stated; modified itt; R0026313:Table 3 | ||
| 52 | A2 | change | -1.51 kg | -2.28 to -0.73 | not stated; modified itt; R0026313:Table 3 | ||
| 52 | A3 | change | -2.28 kg | -3.05 to -1.52 | not stated; modified itt; R0026313:Table 3 |
HbA1c below 7 percent (5 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 28 | A1 | responders | 44.7 | 38.3 to 51.2 | 228 | not stated; modified itt; registry:outcomes | |
| 28 | A1 vs A2 | rd | 17.9 | not stated; modified itt; registry:outcomes | |||
| 28 | A1 vs A3 | rd | 25.6 | not stated; modified itt; registry:outcomes | |||
| 28 | A2 | responders | 26.9 | 21.1 to 32.6 | 227 | not stated; modified itt; registry:outcomes | |
| 28 | A3 | responders | 19.1 | 14.1 to 24.2 | 230 | not stated; modified itt; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (3 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 231 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 230 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 1 / 233 | not stated; safety; registry:adverse_events |
Systolic blood pressure change (8 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 28 | A1 vs A3 | md | -2.4 mmHg | 1.06 | -4.5 to -0.4 | not stated; modified itt; registry:outcomes | |
| 28 | A1 | change | -4.3 mmHg | 0.8 | 228 | hypothetical; modified itt; R0024738:Results | |
| 28 | A1 | change | -4.3 mmHg | -5.8 to -2.7 | 228 | not stated; modified itt; registry:outcomes | |
| 28 | A1 vs A2 | md | -3.0 mmHg | 1.08 | -5.2 to -0.9 | not stated; modified itt; registry:outcomes | |
| 28 | A2 | change | -1.2 mmHg | -2.8 to 0.4 | 227 | not stated; modified itt; registry:outcomes | |
| 28 | A2 | change | -1.2 mmHg | 0.8 | 227 | hypothetical; modified itt; R0024738:Results | |
| 28 | A3 | change | -1.8 mmHg | -3.4 to -0.3 | 230 | not stated; modified itt; registry:outcomes | |
| 28 | A3 | change | -1.8 mmHg | 0.8 | 230 | hypothetical; modified itt; R0024738:Results |
Weight loss of 5 percent or more (5 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 28 | A1 | responders | 33.3 | 27.2 to 39.5 | 228 | not stated; modified itt; registry:outcomes | |
| 28 | A1 vs A2 | rd | 19.7 | not stated; modified itt; registry:outcomes | |||
| 28 | A1 vs A3 | rd | 13.3 | not stated; modified itt; registry:outcomes | |||
| 28 | A2 | responders | 13.7 | 9.2 to 18.1 | 227 | not stated; modified itt; registry:outcomes | |
| 28 | A3 | responders | 20.0 | 14.8 to 25.2 | 230 | not stated; modified itt; registry:outcomes |
All cause mortality (3 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 231 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 230 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 2 / 233 | not stated; safety; registry:adverse_events |
Serious adverse events (3 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 17 / 231 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 18 / 230 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 18 / 233 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 231 | not stated; randomized; registry:flow | ||||
| A2 | events | 12 / 231 | not stated; randomized; registry:flow | ||||
| A3 | events | 6 / 233 | not stated; randomized; registry:flow |
Nausea (3 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13 / 231 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 26 / 230 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 10 / 233 | not stated; safety; registry:adverse_events |
Vomiting (3 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 231 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 12 / 230 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 7 / 233 | not stated; safety; registry:adverse_events |
Diarrhea (3 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13 / 231 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 17 / 230 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 11 / 233 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (9 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 231 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A1 | events | 1 / 231 | not stated; safety; biliary dyskinesia; registry:adverse_events | ||||
| A1 | events | 1 / 231 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A2 | events | 0 / 230 | not stated; safety; biliary dyskinesia; registry:adverse_events | ||||
| A2 | events | 1 / 230 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 0 / 230 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 0 / 233 | not stated; safety; biliary dyskinesia; registry:adverse_events | ||||
| A3 | events | 0 / 233 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A3 | events | 0 / 233 | not stated; safety; cholecystitis; registry:adverse_events |
Acute pancreatitis (3 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 231 | not stated; safety; pancreatic necrosis; registry:adverse_events | ||||
| A2 | events | 0 / 230 | not stated; safety; pancreatic necrosis; registry:adverse_events | ||||
| A3 | events | 0 / 233 | not stated; safety; pancreatic necrosis; registry:adverse_events |
Suicidal ideation or behavior (3 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 231 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A2 | events | 0 / 230 | not stated; safety; suicidal ideation; registry:adverse_events | ||||
| A3 | events | 1 / 233 | not stated; safety; suicidal ideation; registry:adverse_events |
Pancreatic cancer (3 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 231 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 230 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 233 | not stated; safety; registry:adverse_events |