Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted in Asia.

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

The registry classes the interventions as drug.

Who Took Part

458 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 60 days prior to day of screening.

The full record lists 5 inclusion and 16 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

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2017-01-10 with completion listed for 2018-07-12.

It ran at 34 sites in Japan (34).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Treatment-emergent Adverse Events (TEAEs) (time frame: Weeks 0-57).

It also tracked 32 secondary outcomes, for example Change in HbA1c, Change in Fasting Plasma Glucose, Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile, Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals, Change in Body Weight (kg) and Change in Body Weight (%).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Dulaglutide in 458 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 Dulaglutide compound page, all human trials.