A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

What Was Tested

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

People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin).

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

The registry classes the interventions as drug.

Who Took Part

961 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 equal to or above18 years at the time of signing informed consent. Diagnosed with T2D at least 180 days prior to the day of screening.

The full record lists 5 inclusion and 3 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind 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.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-06-19 with completion listed for 2020-09-18.

It ran at 129 sites in United States (61), Hungary (12), Slovakia (11), Poland (10), Canada (8) and Greece (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: Week 0, week 40).

It also tracked 10 secondary outcomes, for example Change in Body Weight, Change in Fasting Plasma Glucose (FPG), Change in Body Mass Index (BMI), Change in Waist Circumference, Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes and Change in Pulse Rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 961 people.

With 961 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.