Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

What Was Tested

This registered phase 3 trial tested Semaglutide.

This trial is globally conducted.

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

The registry classes the interventions as drug.

Who Took Part

504 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. Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening. Sodium glucose co-transporter 2 inhibitors. Informed consent for the extension phase obtained before any trial-related activities for the extension phase. On randomised treatment with or without rescue medication at week 52.

The full record lists 12 inclusion and 14 exclusion criteria; among the exclusions: any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol; family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma; history of pancreatitis (acute or chronic).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2016-09-20 with completion listed for 2018-02-28.

It ran at 83 sites in United States (37), Turkey (Türkiye) (9), Switzerland (8), Belgium (7), South Korea (7) and Norway (5).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 68 secondary outcomes, for example Change in Body Weight, Change in HbA1c, Change in FPG, Change in Body Weight (%), Change in BMI and Change in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 504 people.

With 504 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.