Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
once-weekly s.c. semaglutide (0.5 mg) | increase | treatment discontinuation rate | Japanese adults with type 2 diabetes | 2.9% | prematurely discontinued treatment | #1 |
once-weekly s.c. semaglutide (1.0 mg) | increase | treatment discontinuation rate | Japanese adults with type 2 diabetes | 14.7% | prematurely discontinued treatment | #2 |
once-daily oral sitagliptin 100 mg | increase | treatment discontinuation rate | Japanese adults with type 2 diabetes | 2.9% | prematurely discontinued treatment | #3 |
once-weekly s.c. semaglutide (0.5 mg) | increase | treatment-emergent adverse events (TEAEs) | Japanese adults with type 2 diabetes | 74.8% | were reported | #4 |
once-weekly s.c. semaglutide (1.0 mg) | increase | treatment-emergent adverse events (TEAEs) | Japanese adults with type 2 diabetes | 71.6% | were reported | #5 |
once-daily oral sitagliptin 100 mg | increase | treatment-emergent adverse events (TEAEs) | Japanese adults with type 2 diabetes | 66.0% | were reported | #6 |
once-weekly s.c. semaglutide (0.5 mg) | decrease | glycated haemoglobin (HbA1c) | Japanese adults with type 2 diabetes | 1.9% | decreased | #7 |
once-weekly s.c. semaglutide (1.0 mg) | decrease | glycated haemoglobin (HbA1c) | Japanese adults with type 2 diabetes | 2.2% | decreased | #8 |
once-daily oral sitagliptin 100 mg | decrease | glycated haemoglobin (HbA1c) | Japanese adults with type 2 diabetes | 0.7% | decreased | #9 |
once-weekly s.c. semaglutide (0.5 mg) | decrease | body weight | Japanese adults with type 2 diabetes | 2.2 kg | reduced | #10 |
once-weekly s.c. semaglutide (1.0 mg) | decrease | body weight | Japanese adults with type 2 diabetes | 3.9 kg | reduced | #11 |
AIMS: To assess the safety and efficacy of monotherapy with once-weekly subcutaneous (s.c.) semaglutide vs sitagliptin in Japanese people with type 2 diabetes (T2D). METHODS: In this phase IIIa randomized, open-label, parallel-group, active-controlled, multicentre trial, Japanese adults with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed out during the run-in period) received once-weekly s.c. semaglutide (0.5 or 1.0 mg) or once-daily oral sitagliptin 100 mg. The primary endpoint was number of treatment-emergent adverse events (TEAEs) after 30 weeks. RESULTS: Overall, 308 participants were randomized and exposed to treatment, with similar baseline characteristics across the groups. In total, 2.9% of participants in both the semaglutide 0.5 mg and the sitagliptin group prematurely discontinued treatment, compared with 14.7% in the semaglutide 1.0 mg group. The majority of discontinuations in the semaglutide 0.5 and 1.0 mg groups were attributable to adverse events (AEs). More TEAEs were reported in semaglutide- vs sitagliptin-treated participants (74.8%, 71.6% and 66.0% in the semaglutide 0.5 mg, semaglutide 1.0 mg and sitagliptin groups, respectively). AEs were mainly mild to moderate. Gastrointestinal AEs, most frequently reported with semaglutide, diminished in frequency over time. The mean glycated haemoglobin (HbA1c [baseline 8.1%]) decreased by 1.9% and 2.2% with semaglutide 0.5 and 1.0 mg, respectively, vs 0.7% with sitagliptin (estimated treatment difference [ETD] vs sitagliptin -1.13%, 95% confidence interval [CI] -1.32; -0.94, and -1.44%, 95% CI -1.63; -1.24; both P < .0001). Body weight (baseline 69.3 kg) was reduced by 2.2 and 3.9 kg with semaglutide 0.5 and 1.0 mg, respectively (ETD -2.22 kg, 95% CI -3.02; -1.42 and -3.88 kg, 95% CI -4.70; -3.07; both P < .0001). CONCLUSIONS: In Japanese people with T2D, more TEAEs were reported with semaglutide than with sitagliptin; however, the semaglutide safety profile was similar to that of other glucagon-like peptide-1 receptor agonists. Semaglutide significantly reduced HbA1c and body weight compared with sitagliptin.