Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

What Was Tested

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

This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes.

This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines.

Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets.

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

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female. Age ≥18 and \<60 years at the time of signing the informed consent. Diagnosed with type 2 diabetes mellitus within 24 months from the day of screening. Body mass index ≥25.0 kilogram per square meter (kg/m\^2).

How the Study Was Run

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

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.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-01-26 with completion listed for 2025-01-24.

It ran at 100 sites in India (31), Poland (12), Greece (10), Malaysia (8), Bulgaria (7) and Romania (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in glycated haemoglobin (HbA1c) (time frame: From randomisation (week 0) to week 52).

It also tracked 44 secondary outcomes, for example Change in body weight, Change in fasting plasma glucose (FPG), Change in 7 point self measured plasma glucose (SMPG) mean profile, Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments, Relative change in body weight and Change in waist circumference.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.