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Efficacy and safety of once-weekly semaglutide 2·0 mg vs 1·0 mg in patients with type 2 diabetes (SUSTAIN FORTE): A double-blind, randomised, phase 3B trial

The Lancet Diabetes & Endocrinology Aug 21, 2021

Frías JP, Auerbach P, Bajaj HS, et al. - Findings demonstrated the superiority of semaglutide 2·0 mg over 1·0 mg in decreasing HbA 1c , with additional body weight loss and a similar safety profile. A treatment intensification choice is afforded by this higher dose for type 2 diabetes cases managed with semaglutide in requirement of additional glycaemic control.

  • A 40-week, phase 3B trial (SUSTAIN FORTE) was conducted.

  • This study involved patients (n = 961; mean age 58·0 years) with inadequately controlled type 2 diabetes (HbA 1c 8·0–10·0%) with metformin and with or without sulfonylurea.

  • These patients were randomized (1:1) to 2·0 mg or 1·0 mg once-weekly semaglutide.

  • Outcomes were assessed via trial product estimand (no treatment cessation or without rescue medication) and treatment policy estimand (irrespective of treatment cessation or rescue medication) strategies.

  • At week 40, mean change in HbA1c was −2·2 percentage points with semaglutide 2·0 mg and −1·9 percentage points with semaglutide 1·0 mg (trial product estimand).

  • Such estimates were −2·1 percentage points with semaglutide 2·0 mg and −1·9 percentage points with semaglutide 1·0 mg (treatment policy estimand) at week 40.

  • Similar serious adverse events were noted between treatment groups.

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