Table 2.
Summary of the SUSTAIN safety outcomes8 9 11 15–21
| Trial (n) | Doses and comparators | Duration in weeks | AE (%) | Discontinuation due to AE (%) | GI AE (%): severe, moderate, mild | Discontinuation due to GI AE (%) | Severe or BG-confirmed hypoglycemia (%) |
| SUSTAIN 1 (n=388)13 | SC semaglutide 0.5 mg | 30 | 64 | 6 | 38:<1, 15, 30 | 4 | None |
| SC semaglutide 1.0 mg | 56 | 5 | 38: 2, 13, 32 | 3 | |||
| Placebo | 53 | 2 | 15: 0, 4, 12 | <1 | |||
| SUSTAIN 2 (n=1231)8 | SC semaglutide 0.5 mg | 56 | 75 | 8 | 44: 3, 14, 37 | 7 | NR |
| SC semaglutide 1.0 mg | 71 | 10 | 40: 3, 12, 35 | 8 | |||
| Sitagliptin 100 mg | 72 | 3 | 24: 1, 5, 20 | 3 | |||
| SUSTAIN 3 (n=809)9 | SC semaglutide 1.0 mg | 56 | 75 | 9 | NR | NR | two events* |
| Exenatide ER 2 mg | 76 | 7 | |||||
| SUSTAIN 4 (n=1089)15 | SC semaglutide 0.5 mg | 30 weeks | 70 | 6 | 41: 2, 10, 36 | 3 | NR |
| SC semaglutide 1.0 mg | 73 | 7 | 43: 2, 14, 38 | 5 | |||
| Insulin glargine | 65 | 1 | 15: 1, 4, 12 | 0 | |||
| SUSTAIN 5 (n=397)12 | SC semaglutide 0.5 mg | 30 | 69 | 5 | NR | NR | 8% |
| SC semaglutide 1.0 mg | 64 | 6 | 11% | ||||
| Placebo | 58 | <1 | 5% | ||||
| SUSTAIN 6 (n=3297)11 | SC semaglutide 0.5 mg | 104 | 90 | 12 | 51 | NR | 23% |
| SC semaglutide 1.0 mg | 89 | 15 | 52 | 22% | |||
| Placebo | 91 | 6 | 36 | 22% | |||
| Placebo | 89 | 8 | 35 | 21% | |||
| SUSTAIN 7 (n=1201)16 | SC semaglutide 0.5 mg | 40 | 68 | 8 | 43: 3, 13, 36 | 5 | 3% |
| Dulaglutide 0.75 mg | 62 | 5 | 33: 1, 7, 28 | 2 | 1% | ||
| SC semaglutide 1.0 mg | 69 | 10 | 44: 2, 16, 38 | 6 | 2% | ||
| Dulaglutide 1.5 mg | 74 | 7 | 48: 3, 13, 42 | 5 | 2% | ||
| SUSTAIN 8 (n=788)17 | SC semaglutide 1.0 mg | 52 | 76 | 10 | 47 | 7 | 2% |
| Canagliflozin 300 mg | 72 | 5 | 28 | 1 | 1% | ||
| SUSTAIN 9 (n=302)14 | SC semaglutide 1.0 mg | 30 | 69 | 9 | 37: 1, 14, 31 | 7 | 11% |
| Placebo | 60 | 2 | 13: 0, 3, 11 | 0 | 2% | ||
| SUSTAIN 10 (n=577)18 | SC semaglutide 1.0 mg | 30 | 71 | 11 | 44 | 7 | NR |
| Liraglutide 1.2 mg | 66 | 7 | 38 | 4 |
*The two events of ‘Severe or BG-confirmed Hypoglycemia’ during SUSTAIN 3 were both in the SC semaglutide 1.0 mg group.
AE, adverse events; BG, blood glucose; ER, extended release; GI, gastrointestinal; NR, not recorded; SC, subcutaneous; SUSTAIN, Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes.