A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Semaglutide.

This trial is conducted globally.

The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.

It had two arms (groups): Oral semaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 3183 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.

Examples of who could join: Male or female diagnosed with type 2 diabetes. Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: current or previous (within 90 days prior to screening) treatment with any glp-1 (glucagon-like peptide-1) receptor agonist, dpp-4 (dipeptidyl peptidase-4) inhibitor or pramlintide; family or personal history of multiple endocrine neoplasia type 2 (men 2) or medullary thyroid carcinoma (mtc); history of pancreatitis (acute or chronic).

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.

The Semaglutide group and the comparison group ran side by side rather than switching.

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 2017-01-17 with completion listed for 2018-09-25.

It ran at 228 sites in United States (71), India (19), Germany (12), Spain (11), Turkey (Türkiye) (11) and Malaysia (10).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 17 secondary outcomes, for example Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint, Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction, Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke, Time to First AE Leading to Permanent Trial Product Discontinuation, Number of Serious Adverse Events and Change in Eye Examination Category.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 3183 people.

With 3183 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.