Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial

What Was Tested

This randomized controlled trial paper looks at Liraglutide.

Type 1 diabetes is characterised by progressive loss of functional β-cell mass, necessitating insulin treatment.

Who Took Part

By PubMed's age tags, the people studied were young adults and adults, both men and women.

Eligible participants were adults aged 18-45 years with recently diagnosed type 1 diabetes and residual β-cell function.

Individuals with unstable type 1 diabetes (defined by an episode of severe diabetic ketoacidosis within 2 weeks of enrolment) or active or latent chronic infections were excluded.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and parallel-group study.

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.

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

A placebo (an inactive look-alike) gave the Liraglutide group a baseline to be compared against.

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

The timeline in the abstract includes 2 weeks.

This randomised, parallel-group, placebo-controlled, double-dummy, double-blind, phase 2 trial was done at 94 sites (university hospitals and medical centres) in 17 countries.

Participants were randomly assigned (1:1:1:1), with stratification by baseline stimulated peak C-peptide concentration (mixed-meal tolerance test [MMTT]), to the combination of anti-IL-21 and liraglutide, anti-IL-21 alone, liraglutide alone, or placebo, all as an adjunct to insulin.

Investigators, participants, and funder personnel were masked throughout the treatment period.

The primary outcome was the change in MMTT-stimulated C-peptide concentration at week 54 (end of treatment) relative to baseline, measured via the area under the concentration-time curve (AUC) over a 4 h period for the full analysis set (intention-to-treat population consisting of all participants who were randomly assigned).

After treatment cessation, participants were followed up for an additional 26-week off-treatment observation period.

What Was Measured

Topics PubMed links to this paper include Antibodies, Monoclonal, B-Lymphocytes, Diabetes Mellitus, Type 1, Hypoglycemic Agents, Interleukins, Liraglutide and Interleukin-21.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Liraglutide over 2 weeks.

The abstract goes on to report its results in about 12 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Liraglutide compound page.