Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01394952 REWIND | Diabetes Mellitus, Type 2 | Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years) | Dulaglutide | 594 Participants |
| Placebo | 663 Participants | |||
| NCT01621178 AWARD-7 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, 26 Weeks | Dulaglutide 0.75 mg | -1.12 percentage of HbA1c (±0.12 Standard Error) |
| Dulaglutide 1.5 mg | -1.19 percentage of HbA1c (±0.13 Standard Error) | |||
| Insulin Glargine | -1.13 percentage of HbA1c (±0.12 Standard Error) | |||
| NCT01644500 AWARD-CHN1 | Diabetes Mellitus, Type 2 | Change From Baseline in HbA1c at 26 Weeks Baseline, 26 Weeks | 0.75 mg Dulaglutide | -1.22 percentage of HbA1c (±0.069 Standard Error) |
| 1.5 mg Dulaglutide | -1.48 percentage of HbA1c (±0.069 Standard Error) | |||
| Glimepiride | -0.92 percentage of HbA1c (±0.069 Standard Error) | |||
| NCT01648582 AWARD-CHN2 | Diabetes Mellitus, Type 2 | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks Baseline, 26 Weeks | 0.75 mg Dulaglutide | -1.33 percentage of HbA1c (±0.067 Standard Error) |
| 1.5 mg Dulaglutide | -1.73 percentage of HbA1c (±0.067 Standard Error) | |||
| Insulin Glargine | -1.16 percentage of HbA1c (±0.067 Standard Error) | |||
| NCT01769378 AWARD-8 | Diabetes Mellitus, Type 2 | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks Baseline, 24 Weeks | Dulaglutide | -1.38 percent change of HbA1c (±0.08 Standard Error) |
| Placebo | -0.11 percent change of HbA1c (±0.14 Standard Error) | |||
| NCT02152371 AWARD-9 | Diabetes Mellitus, Type 2 | Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) Baseline, 28 Weeks | Dulaglutide + Insulin Glargine | -1.44 percentage of change (±0.09 Standard Error) |
| Placebo + Insulin Glargine | -0.67 percentage of change (±0.09 Standard Error) | |||
| NCT02597049 AWARD-10 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand) Baseline, Week 24 | 0.75 mg Dulaglutide | -1.21 percentage of HbA1c (±0.064 Standard Error) |
| 1.5 mg Dulaglutide | -1.34 percentage of HbA1c (±0.064 Standard Error) | |||
| Placebo | -0.54 percentage of HbA1c (±0.064 Standard Error) | |||
| NCT02597049 AWARD-10 | Diabetes Mellitus, Type 2 | Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand) Baseline, Week 24 | 0.75 mg Dulaglutide | -1.19 percentage of HbA1c (±0.063 Standard Error) |
| 1.5 mg Dulaglutide | -1.33 percentage of HbA1c (±0.063 Standard Error) | |||
| Placebo | -0.51 percentage of HbA1c (±0.065 Standard Error) | |||
| NCT02648204 SUSTAIN 7 | Diabetes Mellitus, Type 2 | Change in HbA1c Week 0, week 40 | Dulaglutide 0.75 mg | -1.11 percentage of HbA1c (±0.05 Standard Error) |
| Dulaglutide 1.5 mg | -1.37 percentage of HbA1c (±0.06 Standard Error) | |||
| Semaglutide 0.5 mg | -1.51 percentage of HbA1c (±0.06 Standard Error) | |||
| Semaglutide 1.0 mg | -1.78 percentage of HbA1c (±0.06 Standard Error) | |||
| NCT02787551 LixiLan-G | Diabetes Mellitus, Type 2 | Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period Baseline, Week 26 | GLP-1 Receptor Agonist | -0.38 percentage of HbA1c (±0.048 Standard Error) |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -1.02 percentage of HbA1c (±0.048 Standard Error) | |||
| NCT02787551 LixiLan-G | Diabetes Mellitus, Type 2 | Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period Baseline, Week 52 | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | -1.01 percentage of HbA1c (±0.063 Standard Error) |
| NCT02963766 AWARD-PEDS | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 Baseline, Week 26 | Placebo | 0.5 percentage of HbA1C (±0.24 Standard Error) |
| Pooled Dulaglutide | -0.7 percentage of HbA1C (±0.16 Standard Error) | |||
| NCT03015220 PIONEER 10 | Diabetes Mellitus, Type 2 | Number of Treatment-emergent Adverse Events (TEAEs) Weeks 0-57 | Dulaglutide 0.75 mg | 178 Events |
| Oral Semaglutide 14 mg | 324 Events | |||
| Oral Semaglutide 3 mg | 330 Events | |||
| Oral Semaglutide 7 mg | 350 Events | |||
| NCT03495102 AWARD-11 | Diabetes Mellitus, Type 2 | Change in Hemoglobin A1c (HbA1c) From Baseline Baseline, Week 36 | Dulaglutide 1.5 mg | -1.53 Percentage of HbA1c (±0.04 Standard Error) |
| Dulaglutide 3 mg | -1.71 Percentage of HbA1c (±0.04 Standard Error) | |||
| Dulaglutide 4.5 mg | -1.87 Percentage of HbA1c (±0.04 Standard Error) | |||
| NCT03684642 AMPLITUDE-D | Diabetes Mellitus, Type 2 | Change From Baseline to Week 56 in HbA1c Baseline to Week 56 | Dulaglutide 1.5 mg | -1.09 percentage of HbA1c (±0.06 Standard Error) |
| Efpeglenatide 4 mg | -1.12 percentage of HbA1c (±0.06 Standard Error) | |||
| Efpeglenatide 6 mg | -1.17 percentage of HbA1c (±0.06 Standard Error) | |||
| NCT03861052 SURPASS J-mono | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 52 | 0.75 mg Dulaglutide | -1.29 percentage of HbA1c (±0.065 Standard Error) |
| 10 mg Tirzepatide | -2.55 percentage of HbA1c (±0.067 Standard Error) | |||
| 15 mg Tirzepatide | -2.82 percentage of HbA1c (±0.066 Standard Error) | |||
| 5 mg Tirzepatide | -2.37 percentage of HbA1c (±0.066 Standard Error) | |||
| NCT04591626 AWARD-CHN3 | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 28 | 1.5 mg Dulaglutide | -2.03 Percentage of HbA1c (±0.076 Standard Error) |
| Placebo | -1.08 Percentage of HbA1c (±0.073 Standard Error) | |||
| NCT04809220 AWARD-JPN | Diabetes Mellitus, Type 2 | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 Baseline, Week 26 | Dulaglutide 0.75 mg | -1.25 Percentage of HbA1c (±0.060 Standard Error) |
| Dulaglutide 1.5 mg | -1.53 Percentage of HbA1c (±0.043 Standard Error) |