Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

The majority of people with type 2 diabetes (T2D) are overweight, and while weight gain is a major contributor to diabetes, a minority of patients with T2D are not overweight or obese.

The reasons why lean or normal body weight individuals develop T2D (lean-T2D) are not yet understood.

T2D occurs when the body does not produce enough insulin, or becomes less sensitive to its effects.

It had two arms (groups): Liraglutide-Pioglitazone (active comparator) and Pioglitazone-Liraglutide (active comparator).

Participants randomised to receive liraglutide treatment for 16 weeks, followed by an 8 week washout then commencing 16 weeks of treatment with pioglitazone.

Participants randomised to receive pioglitazone treatment for 16 weeks, followed by an 8 week washout then commencing 16 weeks of treatment with liraglutide.

The registry classes the interventions as drug.

More on the Plan

This is a single centre, open-label, randomized, cross-over study.

Participants will attend 4 visits in total over the course of approximately 40 weeks.

Two cohorts of patients will be recruited: 28 lean-T2D patients and 28 obese-T2D patients.

Potential participants will be invited to the research centre for a screening/ baseline visit (Visit 1).

Who Took Part

57 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: Men and women\>18 years of age;. Normal body weight (18.5 ≤ BMI ≤25 kg/m2);. T2D patients can be on treatment with oral glucose lowering therapies, and if they are, they must have been on these treatments for at least 12 weeks prior to screening;. Agreement to maintain prior diet and exercise habits for the duration of the study. Men and women\>18 years of age;.

The full record lists 10 inclusion and 14 exclusion criteria; among the exclusions: any type of diabetes other than t2d;; known hf;; participation in a clinical trial of an investigational medicinal product (ctimp) in the preceding 12 weeks;.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

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

It started in 2020-12-01 with completion listed for 2022-10-31.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in myocardial perfusion after treatment (time frame: 40 weeks).

It also tracked 7 secondary outcomes, for example Myocardial energetics (PCr/ATP ratio), Myocardial steatosis (myocardial triglyceride content), Myocardial function, Insulin resistance (HOMA-IR), Physical performance and Hepatic steatosis (hepatic triglyceride content).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 57 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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