Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity

What Was Tested

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

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

The study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine.

Participants will either get semaglutide tablets or empagliflozin tablets.

It had two arms (groups): Oral semaglutide (experimental) and Empagliflozin (active comparator).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex.

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

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: C-peptide less than (\<)1.5 nanograms per milliliter (ng/mL) at screening; positive insulinoma associated-protein 2 (ia-2) antibodies or anti-glutamic acid decarboxylase (anti-gad) antibodies; history of major surgical procedures involving the stomach or small intestine potentially affecting absorption of drugs and/or nutrients.

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 2022-10-06 with completion listed for 2024-10-02.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No) (time frame: At week 104).

It also tracked 21 secondary outcomes, for example Change in HbA1c, Change in fasting plasma glucose (FPG), Change in self-measured plasma glucose (SPMG) 7-point mean profile, Change in self-measured plasma glucose (SPMG) mean post prandial increments, Time to additional anti-diabetic medication and Change in body weight.

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It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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