A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Semaglutide.

The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine).

Researchers will test semaglutide to see how well it works compared to placebo.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (oral semaglutide) (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 521 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: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, age above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: family or personal history of multiple endocrine neoplasia type 2 (men 2) or medullary thyroid carcinoma (mtc). family is defined as a first degree relative; history or presence 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

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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, care provider, investigator and outcomes assessor.

It started in 2019-10-01 with completion listed for 2021-09-23.

It ran at 66 sites in China (48), Ukraine (7), Hungary (4), Taiwan (3), Algeria (2) and Serbia (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Haemoglobin (HbA1c) (time frame: Baseline (Week 0), Week 26).

It also tracked 53 secondary outcomes, for example Change From Baseline in Body Weight (Kilograms [kg]), Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile, Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals), Change From Baseline in Body Weight (Percentage [%]) and Change From Baseline in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 521 people.

With 521 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.