Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted globally.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 1864 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: Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: family or personal history of multiple endocrine neoplasia type 2 (men 2) or medullary thyroid carcinoma (mtc); history of pancreatitis (acute or chronic); history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

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 2016-02-15 with completion listed for 2017-02-14.

It ran at 242 sites in United States (93), India (18), France (16), Japan (16), United Kingdom (15) and Romania (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c: Week 26 (time frame: Week 0, week 26).

It also tracked 42 secondary outcomes, for example Change in Body Weight: Week 26, Change in HbA1c: Weeks 52 and 78, Change in Body Weight (kg): Weeks 52 and 78, Change in Body Weight (%), Change in FPG and Change in BMI.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1864 people.

With 1864 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.