Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1606 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.

Examples of who could join: Male or female, age above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. BMI equal to or above 25 kg/m\^2. No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \*:.

The full record lists 11 inclusion and 3 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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, care provider, investigator and outcomes assessor.

It started in 2021-01-15 with completion listed for 2023-03-07.

It ran at 228 sites in United States (84), India (25), Poland (21), Bulgaria (17), Canada (15) and Hungary (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52) (time frame: Baseline (week 0), week 52).

It also tracked 38 secondary outcomes, for example Change From Baseline in Body Weight (Week 52), Change From Baseline in HbA1c (Week 68), Change From Week 12 in HbA1c (Week 52), Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52), Change From Baseline in FPG (Week 68) and Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1606 people.

With 1606 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.