Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial

What Was Tested

Researchers studied Semaglutide in this randomized controlled trial publication.

Semaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) analogue for type 2 diabetes.

Few clinical trials have reported on the concomitant use of GLP-1 receptor agonists with sodium-glucose cotransporter-2 (SGLT-2) inhibitors.

Who Took Part

According to the abstract, 2 patients were involved.

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

Existing antidiabetic medications, including SGLT-2 inhibitor treatment, were continued for the duration of the trial.

Rescue medication, defined as intensification of background antidiabetic treatment or the initiation of new glucose-lowering medications, could be given to patients meeting specific criteria at the discretion of the investigator.

How the Study Was Run

The researchers set it up as 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.

Blinding on both sides kept the patients and researchers unaware of who received Semaglutide.

The comparison arm used a placebo, so changes seen with Semaglutide could be set against what happens without it.

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

The SUSTAIN 9 double-blind, parallel-group trial was done at 61 centres in six countries (Austria, Canada, Japan, Norway, Russia, and the USA).

The primary outcome was change in HbA1c from baseline at week 30, assessed in the full analysis set (all patients randomly allocated to treatment) using on-treatment data collected before rescue medication was started.

The confirmatory secondary outcome was change in bodyweight from baseline to week 30.

The trial was registered with ClinicalTrials.gov (NCT03086330).

What Was Measured

PubMed files the paper under topics including Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Hypoglycemic Agents, Sodium-Glucose Transporter 2 Inhibitors and Semaglutide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide in 2 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2019 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Semaglutide compound page.