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

What Was Tested

The trial (phase 3) is built around Semaglutide and Liraglutide.

This trial is conducted globally.

It had three arms (groups): Oral Semaglutide (experimental), Liraglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

711 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 for at least 90 days prior to day of screening.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol; family or personal history of multiple endocrine neoplasia type 2 (men 2) or medullary thyroid carcinoma (mtc); history of pancreatitis (acute or chronic).

How the Study Was Run

The set-up was 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 2016-08-10 with completion listed for 2017-08-19.

It ran at 108 sites in United States (40), Hungary (10), Japan (9), Poland (9), Germany (8) and Slovakia (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (Week 26) (time frame: Week 0, week 26).

It also tracked 39 secondary outcomes, for example Change in Body Weight (Week 26), Change in HbA1c (Week 52), Change in Body Weight (Week 52), Change in Body Weight (%), Change in Fasting Plasma Glucose and Change in Body Mass Index.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Liraglutide in 711 people.

With 711 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 and the Liraglutide compound page, all human trials.