Oral semaglutide reduces HbA1c in T2D

  • Rosenstock J & al.
  • JAMA
  • 23 Mar 2019

  • International Clinical Digest
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Takeaway

  • 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

Study design

  • 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.

Key results

  • 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.

Limitations

  • Relatively high discontinuation rates.
  • Adherence not formally measured.