pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Efficacy and safety of once weekly oral semaglutide compared to other antidiabetic drugs for weight loss in adults with type 2 diabetes31-34)
| 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, kg, (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) | |||||
| Compared to other GLP-1 analogues | ||||||||||
| PIONEER 4 | 52 weeks | Semaglutide 14 mg (n=285) | -4.3 kg | 44.7 | 16 | -5 kg | 49.3 | 18 | 7.7 | 8 |
| Liraglutide 1.8 mg once daily (n=284) | -3 kg (-1.3, -2.1 to -0.5, p=0.0019) | 24.5 (2.38, 1.65 to 3.43, p<0.000) | 7 (2.31, 1.33 to 4.01, p=0.0028) | -3.1 kg (-1.8, -2.6 to -1, p<0.000) | 12 (2.65, 1.8 to 3.89, p<0.0001) | 8 (2.91, 1.65 to 5.13, p=0.0002) | 6 | 6 | ||
| Placebo (n=142) | -1 kg (-3.3, -4.3 to -2.4, p<0.0001) | 12 (5.64, 3.17 to 10.02, p<0.0001) | 3 (5.74, 2.14 to 15.36, p=0.0005) | -1.2 kg (-3.8, -4.8 to -2.7, p<0.000) | 12 (6.34, 3.33 to 12.07, p<0.000) | 4 (8.39, 2.79 to 25.26, p=0.0002) | 2.1 | 2 | ||
| PIONEER 9 | 52 weeks | Semaglutide 3 mg (n=49) | 30.6 | 2 | ||||||
| 0 kg (1, -0.1 to 2.1, p=0.0818) | 3 (0.51, 0.07 to 3.85, p=0.5149) | - | -0.3 kg (0.3, -0.8 to 1.4, p=0.5918) | 4 (0.71, 0.14 to 3.52, p=0.6788) | - | |||||
| 0 kg (-0.4, -1.5 to 0.7, p=0.4636) | 3 (0.54, 0.07 to 4.07, p=0.5539) | - | -0.3 kg (-0.3, -1.5 to 0.8, p=0.5636) | 4 (0.64, 0.12 to 3.33, p=0.5966) | - | |||||
| Semaglutide 7 m g (n=49) | 24.5 | 2 | ||||||||
| -0.6 kg (0.4, -0.7 to 1.5, p=0.4685) | 12 (1.59, 0.34 to 7.38, p=0.5526) | - | -0.8 kg (-0.2, -1.3 to 0.9, p=0.7021) | 12 (1.56, 0.43 to 5.61, p=0.4953) | - | |||||
| -0.6 kg (-1, -2.1 to 0.1, p=0.0702) | 12 (1.7, 0.37 to 7.79, p=0.4977) | - | -0.8 kg (-0.9, -2 to 0.3, p=0.1401) | 12 (1.4, 0.36 to 5.5, p=0.6287) | - | |||||
| Semaglutide 14 mg (n=48) | 29.2 | 2.1 | ||||||||
| -2.8 kg (-1.8, -2.9 to -0.7, p=0.0019) | 41 (7.77, 1.96 to 30.73, p=0.0035) | - | -2.6 kg (-2, -3.1 to -0.9, p=0.0003) | 39 (5.97, 1.91 to 18.66, p=0.0021) | - | |||||
| -2.8 kg (-3.2, -4.2 to -2.1, p<0.0001) | 41 (8.27, 2.08 to 32.86, p=0.0027) | - | -2.6 kg (-2.7, -3.8 to -1.5, p<0.0001) | 39 (5.36, 1.55 to 18.51, p=0.0079) | - | |||||
| Placebo (n=49) | -1 kg | 6 | - | -0.6 kg | 8 | - | 10.2 | 0 | ||
| Liraglutide 0.9 mg once daily (n=49; n=48 for adverse events) | 0.4 kg | 5 | - | 0 | 7 | - | 25 | 0 | ||
| PIONEER10 | 52 weeks | Semaglutide 3 mg (n=131) | - | 6 (0.89, 0.25 to 3.16, p=0.8542) | - | - | 5 (0.73, 0.19 to 2.71, p=0.6334) | - | - | 2 |
| Semaglutide 7 mg (n=132) | - | 16 (2.94, 0.96 to 9.01, p=0.0589) | - | - | 17 (3.26, 1.07 to 9.94, p=0.0376) | - | - | 3 | ||
| Semaglutide 14 mg (n=130) | - | 22 (4.23, 1.41 to 12.7, p=0.0102) | - | - | 25 (5.14, 1.71 to 15.46, p=0.0035) | - | - | 4 | ||
| Dulaglutide 0.75 mg once daily, reference (n=65) | - | 6 | - | - | 7 | - | - | 2 | ||
| Compared to SGLT-2 inhibitor | ||||||||||
| PIONEER 2 | 52 weeks | Semaglutide 14 mg (n=411; n=410 for adverse events) | -3.8 kg (-0.2, -0.9 to 0.5, p=0.6231) | 40.4 (1.04, 0.78 to 1.39, p=0.7801) | - | -4.7 kg (-0.9, -1.6 to -0.2, p=0.0114) | 47.1 (1.27, 0.94 to 1.73, p=0.1161) | - | 36.4 | 8 |
| Empagliflozin 25 mg once daily, reference (n=410; n=409 for adverse events) | -3.6 kg | 39.2 | - | -3.8 kg | 42.1 | - | 7.3 | 0.7 | ||
CI: confidence interval; ETD: estimated treatment difference; GI: gastrointestinal; GLP-1: glucagon-like peptide-1; OR: odds ratio; SGLT-2: sodium-glucose transport protein 2