Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes

What Was Tested

The trial (phase 2) is built around Liraglutide.

Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels.

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

Treatment with placebo once daily for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 30 years.

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

Examples of who could join: Written informed consent for participation of the study, given before undergoing any study-specific procedures. 18-30 years of age (age interval inclusive of both the ends). Both males and females are eligible for the study. Clinical diagnose of T1D. Five or more years duration of disease.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: inability to provide informed consent; mental incapacity; unwillingness or language barrier precluding adequate understanding or cooperation.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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, investigator and outcomes assessor.

It started in 2015-11 with completion listed for 2020-09.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 17 secondary outcomes, for example Change in C-peptide between 6 and 52 weeks of study, Change in HbA1c between 6 and 52 weeks of study, Change in glucose variability between 6 and 52 weeks of study, Change in hypoglycemia frequency between 6 and 52 weeks of study, Change in QoL between 6 and 52 weeks of study and Change in QoL between after and prior to treatment with liraglutide.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 18 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.