Investigating the Effect of Liraglutide on the Endogenous Glucose Production During in Tye 1 Diabetes Subjects

What Was Tested

This registered phase 2 trial tested Liraglutide.

Wash-out period between treatments will be 1 month.

The trial can be divided into the following periods: * Screening * Treatment period 1 * Washout period * Treatment period 2 * Follow up Visit Mixed Meal Tolerance Test (MMTT) enriched with paracetamol: At the beginning and end of each period a MMTT (Fortimel complete) enriched with paracetamol will be performed to assess the remaining beta-cell function via obtained maximal plasma C-peptide levels as well as the gastric emptying.

It had two arms (groups): Liraglutide (active comparator) and Placebo (placebo comparator).

3-month treatment of liraglutide.

3-month treatment of placebo.

The registry classes the interventions as drug.

Who Took Part

14 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Type 1 diabetes mellitus as diagnosed (including I - III):. Male or female, aged 18 - 64 years (both inclusive). Body mass index (BMI) 20.0 - 25.0 kg/m2 (both inclusive).

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; use of liraglutide or exenatide within 3 months before screening; severe hypoglycaemia within 1 month of screening.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

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.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2015-01 with completion listed for 2016-05.

It ran at 1 site in Austria.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Area under the curve of the endogenous glucose production from (=EGP) from begin of the hypoglycaemic clamp [amount hidden]/L period until the end of recovery period ([amount hidden]/L), calculated from stable isotope labelled plasma glucose.

It also tracked 16 secondary outcomes, for example Change in number of regulatory T-cells detected by blood (fasting) and measured by a laboratory, Change in function of regulatory T-cells detected by blood (fasting) and measured by a laboratory, Area under the glucose curve during the Mixed Meal Tolerance Test, Area under the c-peptid concentration curve during the Mixed Meal Tolerance Test, Area under the paracetamol concentration curve to calculate gastric emptying during the Mixed Meal Tolerance Test and Area under the insulin curve during the Mixed Meal Tolerance Test.

What This Means in Plain Language

Put simply, this is a phase 2, 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.