- Among adults with type 2 diabetes (T2D) uncontrolled with metformin with/without sulfonylurea, 7 and 14 mg/day oral semaglutide produced significantly greater HbA1c reductions over 26 weeks vs sitagliptin.
- No significant benefit with 3 mg/day.
Why this matters
- Many with T2D do not achieve HbA1c target
- Double-blind, multicenter phase 3a trial, 1864 patients uncontrolled with metformin with/without sulfonylurea, randomly assigned to once-daily 3, 7, or 14 mg oral semaglutide, or 100 mg sitagliptin.
- Funding: Novo Nordisk A/S.
- Primary endpoint, HbA1c change from baseline at 26 weeks:
- −0.6%, −1.0%, and −1.3% for 3, 7, and 14 mg/day semaglutide, respectively; and
- −0.8% for sitagliptin;
- Differences vs sitagliptin were significant for 7- and 14-mg/day semaglutide doses (P<.001 for both but not mg>
- Bodyweight changes were:
- −1.2, −2.2, and −3.1 kg for semaglutide, 3, 7, and 14 mg/day, respectively; and
- −0.6 kg for sitagliptin.
- Significance for the 2 higher semaglutide doses only vs sitagliptin (P<.001>
- Adverse events led to premature discontinuation for:
- 5.6%, 5.8%, and 11.6% in the 3-, 7-, and 14-mg/day semaglutide, respectively; and
- 5.2% for sitagliptin,
- Primarily gastrointestinal adverse events in all groups.
- Relatively high discontinuation rates.
- Adherence not formally measured.