Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

This trial is conducted in Africa, Asia, Europe and South America.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1231 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

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 2013-12-02 with completion listed for 2015-10-12.

It ran at 141 sites in India (19), Russia (19), Japan (14), Turkey (Türkiye) (12), Bulgaria (10) and Portugal (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (Glycosylated Haemoglobin) From Baseline (time frame: Week 0, week 56).

It also tracked 5 secondary outcomes, for example Change in Body Weight From Baseline, Change in Fasting Plasma Glucose (FPG) From Baseline, Change in Systolic and Diastolic Blood Pressure From Baseline and Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1231 people.

With 1231 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.