Lancet (London, England)

Effectiveness and safety of once-daily 25 mg and 50 mg oral semaglutide versus 14 mg in adults with type 2 diabetes

Updated

Abstract

In a trial with 1,606 participants, oral semaglutide 50 mg reduced HbA1c by an average of 2.0 percentage points after 52 weeks.

  • Oral semaglutide at higher doses (25 mg and 50 mg) resulted in greater reductions in HbA1c compared to the approved 14 mg dose.
  • At week 52, the mean change in HbA1c was -1.5 percentage points for 14 mg, -1.8 percentage points for 25 mg, and -2.0 percentage points for 50 mg.
  • Gastrointestinal disorders were reported more frequently with the higher doses (25 mg and 50 mg) compared to the 14 mg dose.
  • Adverse events were reported by 76% of participants in the 14 mg group, 79% in the 25 mg group, and 80% in the 50 mg group.
  • No new safety concerns were identified during the trial, which included ten deaths not deemed treatment related.

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Full Text

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Funding

Competing interests

Declaration of interests VRA reports receiving consultancy fees from Applied Therapeutics, Fractyl, Novo Nordisk, Pfizer, and Sanofi, and research grant support (to their institution) from Applied Therapeutics, Eli Lilly, Fractyl, Novo Nordisk, and Sanofi. LB, EC, and SG are employees and shareholders in Novo Nordisk. JA reports consulting fees or speaking honoraria from Astra Zeneca, Boehringer Ingelheim, Lilly, and Novo Nordisk. FKK reports participating in scientific advisory panels or speakers' bureaus for, consulting fees, or receiving research support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Carmot Therapeutics, Eli Lilly, Gubra, Lupin, MedImmune, MSD–Merck, Mundipharma, Norgine, Novo Nordisk, Pharmacosmos, Sanofi, ShouTi, Zealand Pharma, and Zucara; is a minority shareholder in Antag Therapeutics, and co-owner of the weight loss clinic Medicinsk Vægttabsbehandling ApS. SDP reports consulting fees or speaking honoraria from Abbott, AstraZeneca, Bausch, Bayer, Boehringer Ingelheim, Dexcom, HLS, Janssen, Lilly, Merck, Novo Nordisk, Pfizer, and Sanofi; and research studies for AstraZeneca, Boehringer Ingelheim, Lilly, Medpace, and Novo Nordisk. JBB contracted consulting fees and travel support for contracted activities that are paid to the University of North Carolina by Novo Nordisk and vTv Therapeutics; has received grant support from Dexcom, NovaTarg, Novo Nordisk, Sanofi, Tolerion, and vTv Therapeutics; has received personal compensation for consultation from Alkahest, Altimmune, Anji, AstraZeneca, Bayer, Boehringer Ingelheim, Carmot Therapeutics, CeQur, Cirius Therapeutics, Corcept Therapeutics, Dasman Diabetes Institute (Kuwait), Eli Lilly, Fortress Biotech, GentiBio, Glycadia, Glyscend, Janssen, Mellitus Health, Moderna, Pendulum Therapeutics, Praetego, Sanofi, Stability Health, Terns, and Valo; has received payment for expert testimony from Medtronic; and in lieu of payment for consultation he has received stock or options in Glyscend, Mellitus Health, Pendulum Therapeutics, PhaseBio, Praetego, and Stability Health.
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