The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Exenatide and Liraglutide.

Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.

It had three arms (groups): Liraglutide + Liquid meal test (experimental), Exenatide + Liquid meal test (experimental) and Baseline + Liquid meal test (other).

Baseline day with no additional medication.

The registry classes the interventions as drug, other and procedure.

More on the Plan

Aim: To investigate the glucagonostatic effects of glucagon-like peptide-1 (GLP-1) during prolonged and intermittent stimulation of the GLP-1 receptor independent of the gastric emptying rate.

Glucagon concentrations will be measured following a liquid meal administered in duodenum at baseline and after exenatide, and liraglutide treatment.

Who Took Part

The registry lists 10 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: Type 1 Diabetes.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: history of alcohol and/or drug abuse; pregnancy and lactation; other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-07 with completion listed for 2015-11.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glucagon concentration (postprandial) (time frame: 4 hours).

It also tracked 11 secondary outcomes, for example Postprandial glucose concentrations, glucagon-like peptide-1 (GLP-1), glucagon-like peptide-2 (GLP-2), glucose-dependent insulinotropic polypeptide (GIP), Cholecystokinin (CCK) and Peptide YY (PYY).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Exenatide and Liraglutide in 10 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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