A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Semaglutide.

This trial is conducted in Asia.

All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

It had three arms (groups): one (experimental), one (experimental) and One additional OAD + pre-trial treatment (active comparator).

The registry classes the interventions as drug.

Who Took Part

601 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: Male or female, age at least 20 years at the time of signing informed consent.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol; history of chronic or idiopathic acute pancreatitis; screening calcitonin value above or equal to 50 ng/l (pg/ml).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-08-04 with completion listed for 2016-02-27.

It ran at 43 sites in Japan (43).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Treatment Emergent Adverse Events (TEAEs) (time frame: Weeks 0-56).

It also tracked 2 secondary outcomes, for example Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes and Change in Glycosylated Haemoglobin A1c (HbA1c).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 601 people.

With 601 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.