Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

Current anti-diabetic treatment fails to stop the progressive course of the disease.

Recent studies have revealed a surprisingly high variability in the diabetic phenotype.

The investigators propose that anti-diabetic treatment should ideally target the underlying pathophysiology of each individual patient.

It had two arms (groups): semaglutide (active comparator) and dapagliflozin (active comparator).

The registry classes the interventions as drug.

More on the Plan

The trial is a clinical phase II study that will be randomized and open-label with fixed stratification variables (SIDD and SIRD) to analyze if the response to anti-diabetic drugs differs between patients with distinct pathophysiology, as captured by SIDD and SIRD.

The compounds used are semaglutide and dapagliflozin, which will be randomized to patients of each subgroup using a parallel group design.

The clusters (SIDD and SIRD) will be used as a practical tool to distinguish individuals who are at different ends of the pathophysiological spectrum.

Half of them will have SIDD and half will have SIRD characteristics.

Who Took Part

The registry lists 200 planned participants were the target.

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: Age 18 years or above. Willingness to take injectable and oral medication. Written informed consent.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: • type 1 diabetes, lada, mody, secondary diabetes or history of diabetic ketoacidosis; heart failure nyha class iv; history of acute or chronic pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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 2020-09-10 with completion listed for 2021-12-15.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hba1c (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 200 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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