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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