Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial

What Was Tested

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

Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue in phase 3 development for type 2 diabetes.

Who Took Part

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

Participants did their own injections and were encouraged to administer them on the same day of each week in the same area of their body; the time of day and proximity of meal times was not specified.

Investigators, participants, and the funder of the study remained masked throughout the trial.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Some participants received a placebo instead of Semaglutide, giving a reference point.

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

The researchers did a double-blind, randomised, parallel-group, international, placebo-controlled phase 3a trial (SUSTAIN 1) at 72 sites in Canada, Italy, Japan, Mexico, Russia, South Africa, UK, and USA (including hospitals, clinical research units, and private offices).

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

The primary endpoint was the 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 was registered with ClinicalTrials.gov, number NCT02054897.

What Was Measured

Topics PubMed links to this paper include Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Glycated Hemoglobin, Hypoglycemic Agents, Placebo Effect and Semaglutide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

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

More context: the Semaglutide compound page.