Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

What Was Tested

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

This trial is conducted globally.

All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

731 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.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

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

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2017-02-02 with completion listed for 2018-01-18.

It ran at 118 sites in United States (50), Japan (19), France (12), India (12), Canada (7) and Greece (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (Week 26) (time frame: Week 0, week 26).

It also tracked 36 secondary outcomes, for example Change in Body Weight (Week 26), Change in HbA1c (Week 52), Change in Body Weight (kg) (Week 52), Change in Fasting Plasma Glucose (FPG), Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile and Change in SMPG Mean Postprandial Increment Over All Meals.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 731 people.

With 731 participants it is a large trial for this field.

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.