Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Semaglutide and Liraglutide.

This trial is conducted in Asia.

It had five arms (groups): one (experimental), one (experimental), one (experimental), Oral placebo (placebo comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 243 actual participants took part.

It was open to people of any sex aged from 20 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. Japanese male or female, age above or equal to 20 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening.

The full record lists 5 inclusion and 15 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.

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 2017-01-10 with completion listed for 2018-01-09.

It ran at 16 sites in Japan (16).

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

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Liraglutide in 243 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 and the Liraglutide compound page, all human trials.