Effect of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Apelin.

The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473).

The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.

It had two arms (groups): Apelin then Placebo (other) and Placebo then Apelin (other).

First clamp during which an apelin infusion will be administered followed by a wash-out period and then, a second clamp in which a placebo infusion will be administered.

First clamp during which a placebo infusion will be administered followed by a wash-out period and then, a second clamp in which an apelin infusion will be administered.

The registry classes the interventions as drug.

More on the Plan

Insulin sensitivity is measured using the hyperinsulinemic euglycemic glucose clamp method.

This study could bring new elements for understanding the pathophysiology of insulin resistance and type 2 diabetes mellitus in humans and could lead to the development of innovative therapies in type 2 diabetes mellitus.

Who Took Part

The registry lists 9 actual participants took part.

It was open to men only aged from 40 years up to 65 years.

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

Examples of who could join: Clinical diagnosis of type2 diabetes. Body Mass Index between 27 and 33 kg / cm ². Heart rate between 50 and 80 beats per minute at rest. Good peripheral vein (forearm and back of the hand). Agreement to participate in the establishment of a serum bank.

The full record lists 13 inclusion and 14 exclusion criteria; among the exclusions: insulin therapy or glucagon like peptid 1 (glp-1) analogs therapy in the 6 months before inclusion; repeated a qtc interval\> 450 ms measurement; risk factor for torsade de pointes: myocardial infarction, hypokalemia, family history of long qt syndrome.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Apelin and who got the comparison, which limits bias.

Each person switched between Apelin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Apelin.

Those kept unaware of assignments: participant and investigator.

It started in 2016-05 with completion listed for 2017-04.

It ran at 1 site in France.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Delta between Glucose Infusion Rate (time frame: 240 minutes).

It also tracked 8 secondary outcomes, for example Measure of M-value (a glucose physiological parameter), systolic blood pressure and diastolic blood pressure, heart rate, Measure of QTc interval with electrocardiogram examination, Clinic sign of apelin intolerance and Clinic sign of apelin allergy.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Apelin in 9 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 Apelin compound page, all human trials.