Efficacy and safety of once-weekly semaglutide 2·[amount hidden] versus 1·[amount hidden] in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial

What Was Tested

The paper reports a study of Semaglutide, published as a randomized controlled trial.

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults, both men and women.

The researchers did a 40-week, randomised, active-controlled, parallel-group, double-blind, phase 3B trial (SUSTAIN FORTE) at 125 outpatient clinics in ten countries.

Participants, site personnel, the clinical study group, and investigators were masked to the randomised treatment.

How the Study Was Run

In design terms this was a randomized, double-blind and parallel-group study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

The Semaglutide group and the comparison group ran side by side rather than switching.

Outcomes included change from baseline at week 40 in HbA1c (primary outcome) and bodyweight (secondary confirmatory outcome), evaluated through trial product estimand (no treatment discontinuation or without rescue medication) and treatment policy estimand (regardless of treatment discontinuation or rescue medication) strategies.

This study is registered with ClinicalTrials.gov, NCT03989232; EudraCT, 2018-004529-96; and WHO, U1111-1224-5162.

What Was Measured

Topics PubMed links to this paper include Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Hypoglycemic Agents, Metformin, Sulfonylurea Compounds and Semaglutide.

What This Means in Plain Language

The paper is a randomized, double-blind and parallel-group study of Semaglutide.

Its findings take up roughly 10 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2021 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Semaglutide compound page.