Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial

What Was Tested

This randomized controlled trial paper looks at Semaglutide and Insulin Glargine.

Who Took Part

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

Eligible participants were insulin-naive patients with type 2 diabetes, aged 18 years and older, who had insufficient glycaemic control with metformin either alone or in combination with a sulfonylurea.

In all treatment groups, previous background metformin and sulfonylurea treatment was continued throughout the trial.

How the Study Was Run

The researchers set it up as a randomized, open-label, multicenter and parallel-group study.

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

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Running at several centres spread the Semaglutide study over different clinics and patient groups.

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

The researchers did the randomisation using an interactive voice or web response system.

The primary endpoint was change in mean HbA1c from baseline to week 30 and the confirmatory secondary endpoint was the change in mean bodyweight from baseline to week 30.

This trial is registered with ClinicalTrials.gov, number NCT02128932.

What Was Measured

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

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Semaglutide and Insulin Glargine.

Its findings take up roughly 9 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2017 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Semaglutide compound page and the Insulin Glargine compound page.