Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Semaglutide.

This trial is conducted globally.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 822 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 at least 90 days prior to day of screening.

The full record lists 5 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

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2016-08-10 with completion listed for 2017-08-01.

It ran at 106 sites in United States (48), Spain (9), Greece (7), Croatia (6), Hungary (6) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: Week 0, week 26).

It also tracked 49 secondary outcomes, for example Change in Body Weight (Kg), Change in HbA1c (%), Change in Body Weight (kg), Change in Fasting Plasma Glucose, Change in SMPG : Mean of the 7-point Profile and Change in SMPG : Mean Postprandial Increment Over All Meals.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 822 people.

With 822 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.