Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Liraglutide.

This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes mellitus patients on oral glucose lowering agents, and naive to incretinomimetic.

The two arms will be compared for 14-day changes in insulin secretion and insulin sensitivity.

It had two arms (groups): sub cutaneous liraglutide (experimental) and Oral Vildagliptin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Incretinomimetics include exogenous Glucagon-Like Peptide analogs (GLP1a) such as Liraglutide, and inhibitors of Dipeptidyl peptidase IV (DPP4i) that prolong the half-life of endogenous GLP1 such as Vildagliptin.

It remains unclear which of the two strategies (exogenous GLP1 or prolonging half-life of endogenous GLP1) have better short term effect on insulin sensitivity and insulin secretion in people living with type 2 diabetes.

This study aims to investigate the short-term metabolic effects of a GLP-1 analog Liraglutide versus a DPP4i Vildagliptin.

It is a randomized, controlled, single-blinded clinical trial.

Who Took Part

14 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

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

Examples of who could join: Type 2 diabetes mellitus known for at least one year. Naïve of incretinomimetic treatment.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: change in antidiabetic treatment less than 3 months prior to inclusion; alanine amino transferase \> 3 times the normal values; pregnant or breastfeeding women.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2016-01 with completion listed for 2016-09.

It ran at 1 site in Cameroon.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Insulin sentivity (time frame: 2 weeks).

It also tracked 3 secondary outcomes, for example insulin secretion, lipid profile and body weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 14 people.

Its size is small, so on its own it can only give an early look.

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.