pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Efficacy and safety of once weekly oral semaglutide compared to placebo for weight loss in adults with type 2 diabetes 29, 30, 35, 36)
| Trial | Trial duration | Study drugs | Treatment policy estimand | Trial product estimand | GI adverse events (%) | GI adverse events leading to premature treatment discontinuation (%) | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mean body weight change from baseline (ETD, 95% CI, p-value) | Proportion achieving body weight reduction of ≥5%, % (OR, 95% CI, p-value) | Proportion achieving body weight reduction of ≥10%, % (OR, 95% CI, p-value) | Mean body weight change from baseline (ETD, 95% CI, p-value) | Proportion achieving body weight reduction of ≥5%, % (OR, 95% CI, p-value) | Proportion achieving body weight reduction of ≥10%, % (OR, 95% CI, p-value) | |||||
| PIONEER 1 | 26 weeks | Semaglutide 3 mg (n=175) | -1.5 kg (-0.1, -0.9 to 0.8, p=0.87) | 19.6 (1.3, 0.73 to 2.33, p=0.37) | 2.4 (1.88, 0.34 to 10.44, p=0.47) | -1.7 kg (-0.2, -1 to 0.6, p=0.71) | 21.3 (1.27, 0.7 to 2.31, p=0.43) | 2.7 (1.44, 0.27 to 7.63, p=0.67) | 1.7 | 2.3 |
| Semaglutide 7 mg (n=175) | -2.3 kg (-0.9, -1.9 to 0.1, p=0.09) | 19.6 (1.3, 0.73 to 2.33, p=0.37) | 8.1 (7.74, 1.68 to 35.72, p=0.009) | -2.5 kg (-1, -1.8 to -0.2, p=0.01) | 21.3 (1.27, 0.7 to 2.31, p=0.43) | 8.7 (5.26, 1.22 to 22.72, p=0.03) | 2.3 | 5 | ||
| Semaglutide 14 mg (n=175) | -3.7 kg (-2.3, -3.1 to -1.5, p<0.001) | 41.3 (3.74, 2.18 to 6.41, p<0.001) | 14.4 (12.92, 2.98 to 56.07, p<0.001) | -4.1 kg (-2.6, -3.4 to -1.8, p<0.001) | 44.3 (4.17, 2.38 to 7.29, p<0.001) | 15.4 (10.89, 2.63 to 44.98, p=0.001) | 5.1 | 7.4 | ||
| Placebo, reference (n=178) | -1.4 kg | 14.9 | 1.2 | -1.5 kg | 15.7 | 1.5 | 0.6 | 2.2 | ||
| PIONEER 5 | 26 weeks | Semaglutide 14 mg (n=163) | -3.4 kg (-2.5, -3.2 to -1.8, p<0.0001) | - | - | -3.7 kg (-2.7, -3.5 to -1.9, p<0.0001) | - | - | - | - |
| Placebo, reference (n=161) | -0.9 kg | - | - | -1.1 kg | - | - | - | - | ||
| PIONEER 8 | 52 weeks | Semaglutide 3 mg (n=184) | -0.8 kg (-1.3, -2.4 to -0.3, p=0.0101) | 17.2 (3.63, 1.66 to 7.93, p=0.0012) | 2.3 (2.85, 0.48 to 17.04, p=0.2514) | -1 kg (-1.6, -2.6 to -0.7, p=0.0009) | 25 (4.52, 1.83 to 11.17, p=0.001) | 2.8 (8.34, 0.51 to 137.4, p=0.1378) | 4.9 | 4.9 |
| Semaglutide 7 mg (n=182; n=181 for adverse events) | -3.7 kg (-4.3, -3.6 to -1.4, p<0.0001) | 28.1 (7.12, 3.35 to 15.12, p<0.0001) | 9.9 (13.48, 2.67 to 68.08, p=0.0016) | -2.9 kg (-3.5, -4.5 to -2.6, p<0.0001) | 35.7 (9.83, 4.07 to 23.74, p<0.0001) | 13.9 (41.03, 2.77 to 607.6, p=0.0069) | 6.6 | 8.8 | ||
| Semaglutide 14 mg (n=181) | -3.7 kg (-4.3, -5.3 to -3.2, p<0.0001) | 39.4 (11.96, 5.69 to 25.14, p<0.0001) | 12.4 (17.71, 3.55 to 88.25, p=0.0004) | -4.3 kg (-4.9, -5.9 to -3.9, p<0.0001) | 48.7 (16.83, 7.03 to 40.27, p<0.0001) | 17.4 (65.58, 4.47 to 962.4, p=0.0023) | 10.5 | 13.3 | ||
| Placebo, reference (n=184) | 0.5 kg | 5.2 | 0.6 | 0.6 kg | 5 | 0 | 0.5 | 2.7 | ||
CI: confidence interval; ETD: estimated treatment difference; GI: gastrointestinal; OR: odds ratio