Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

This trial is conducted in Asia, Europe and North America.

Subjects will remain on their pre-trial medication.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 302 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Diagnosed with type 2 diabetes mellitus.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol; subjects with alanine aminotransferase above 2.5 x upper normal limit; family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. family is defined as a first degree relative.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2017-03-15 with completion listed for 2018-07-04.

It ran at 72 sites in United States (43), Canada (8), Norway (7), Russia (5), Austria (4) and Japan (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: Week 0, week 30).

It also tracked 57 secondary outcomes, for example Change in Body Weight (kg), Change in Fasting Plasma Glucose (FPG), Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile, Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals), Change in Fasting Blood Lipid, Total Cholesterol and Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 302 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.