Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Semaglutide.

This trial is conducted globally.

The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes.

The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme.

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: 3297 actual participants took part.

It was open to people of any sex aged from 50 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.

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.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2013-02-21 with completion listed for 2016-03-15.

It ran at 253 sites in United States (97), India (21), Canada (14), Russia (13), Mexico (10) and Turkey (Türkiye) (10).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 15 secondary outcomes, for example Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome, Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome, Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c), Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose, Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight and Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 3297 people.

With 3297 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.