Table 3.
Study design and results of PIONEER trials
| PIONEER | Clinical trial identification number | Population | Duration (weeks) |
Background medication | Semaglutide trial dose & Comparator | Trial product estimand | Treatment policy estimand | ||
|---|---|---|---|---|---|---|---|---|---|
| % HbA1c reduction | Weight loss | % HbA1c reduction | Weight loss | ||||||
| 1 | NCT02906930 | 703 | 26 | None | 3 mg | -0.7 | -0.2 | -0.6 | -0.1 |
| 7 mg | -1.2 | -1.0 | -0.9 | -0.9 | |||||
| 14 mg | -1.4 | -2.6 | -1.1 | -2.3 | |||||
| Placebo | -0.1 | -1.5 | -0.3 | -1.4 | |||||
| 2 | NCT02863328 | 822 | 52 | Metformin | 14 mg | -1.3 | -4.7 | -1.3 | -3.8 |
| Empagliflozin (25 mg) | -0.8 | -3.8 | -0.9 | -3.6 | |||||
| 3 | NCT02607865 | 1864 | 78 | Metformin with/without Sulfonylurea | 3 mg | -0.3 | -1.8 | -0.6 | -1.8 |
| 7 mg | -0.7 | -2.7 | -0.8 | -2.7 | |||||
| 14 mg | -1.1 | -3.5 | -1.1 | -3.2 | |||||
| Sitagliptin (100 mg) | -0.4 | -1.1 | -0.7 | -1.0 | |||||
| 4 | NCT02863419 | 711 | 52 | Metformin with/without SGLT-2 inhibitor | 14 mg Liraglutide | -1.2 | -5.0 | -1.2 | -4.3 |
| (s.c. 1.8 mg) | -0.9 | -3.1 | -0.9 | -3.0 | |||||
| Placebo | +0.2 | -1.2 | -0.2 | -1.0 | |||||
| 5 | NCT02827708 | 324 (with moderate renal impairment) | 26 | Metformin/Sulfonylurea, or both, or Basal insulin with/without Metformin | 14 mg | -1.1 | -3.7 | -1.0 | -3.4 |
| Placebo | -0.1 | -1.1 | -0.2 | -0.9 | |||||
| 6 | NCT02692716 | 3183 (84.7% with CV or CKD) | Event-driven; Median time = 69 weeks | None | 14 mg | -1.0% | 4.2 kg | ||
| Placebo | -0.3% | 0.8 kg | |||||||
| 7 | NCT02849080 | 504 | 52 | One/two amongst Metformin,Sulfonylureas, SGLT-2 inhibitors, or Thiazolidinediones | 14 mg | -1.4 | -2.9 | -1.3 | -2.6 |
| Sitagliptin (100 mg) | -0.7 | -0.8 | -0.8 | -0.7 | |||||
| 8 | NCT03021187 | 731 | 52 | Insulin with/without Metformin | 3 mg | -0.5 | -1.0 | -0.6 | -0.8 |
| 7 mg | -0.8 | -2.9 | -0.8 | -2.0 | |||||
| 14 mg | -1.2 | -4.3 | -1.2 | -3.7 | |||||
| Placebo | 0.0 | +0.6 | -0.2 | +0.5 | |||||
| 9 | NCT03018028 | 243 | 52 | None | 3 mg | -0.9 | 0.0 | -0.9 | -0.3 |
| 7 mg | -1.3 | -0.6 | -1.4 | -0.8 | |||||
| 14 mg | -1.5 | -2.8 | -1.5 | -2.6 | |||||
| Placebo | +0.5 | -1.0 | -0.1 | -0.6 | |||||
| Liraglutide (s.c. 0.9 mg) | -1.1 | +0.4 | -1.2 | 0.0 | |||||
| 10 | NCT03015220 | 458 | 52 | Sulfonylurea/glinide/thia zolidinedione/α-glucosidase inhibitor/SGLT-2 inhibitor monotherapy | 3 mg | -0.7 | +0.1 | -0.9 | 0.0 |
| 7 mg | -1.4 | -1.0 | -1.4 | -0.9 | |||||
| 14 mg | -1.8 | -1.9 | -1.7 | -1.6 | |||||
| Dulaglutide (s.c. 0.75 mg) | -1.3 | +1.1 | -1.4 | +1.0 | |||||
| 11 | NCT04109547 | 664 | 26 | None | 3 mg | - | - | - | - |
| 7 mg | - | - | - | - | |||||
| 14 mg | - | - | - | - | |||||
| Placebo | - | - | - | - | |||||
| 12 | NCT04017832 | 1444 | 26 | Metformin | 3 mg | - | - | - | - |
| 7 mg | - | - | - | - | |||||
| 14 mg | - | - | - | - | |||||
| Placebo | - | - | - | - | |||||
| Sitagliptin (100 mg) | - | - | - | - | |||||
| TEENS | NCT04596631 | 132 (aged 10–17 years) | 52 | Metformin and/or basal insulin |
Semaglutide (maximum tolerated dose) Placebo |
- | - | - | - |