Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Semaglutide.

This trial is conducted in Asia, Europe and the United States of America (USA).

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 397 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.

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2014-12-01 with completion listed for 2015-11-21.

It ran at 99 sites in United States (72), Germany (12), Japan (6), Slovakia (5), Serbia (3) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 30).

It also tracked 7 secondary outcomes, for example Change in Body Weight, Change in Fasting Plasma Glucose (FPG), Change in Systolic and Diastolic Blood Pressure and Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 397 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, all human trials.