A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

What Was Tested

This registered phase 2 trial tested Liraglutide.

This trial is conducted globally.

The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

It had four arms (groups): NNC0114-0006 + Liraglutide (experimental), NNC0114-0006 + Placebo (experimental), Liraglutide + Placebo (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 308 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 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. BMI (body mass index) higher or equal to 18.5 kg/m\^2. Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening. Insulin dependence unless in temporary spontaneous remission (honeymoon period).

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: history of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy; vaccination within 4 weeks before randomisation, visit 3 (v3); receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (v1).

How the Study Was Run

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

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

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 and investigator.

It started in 2015-11-10 with completion listed for 2018-08-31.

It ran at 108 sites in Russia (14), United States (13), United Kingdom (13), Canada (10), Spain (8) and Ukraine (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline.

It also tracked 114 secondary outcomes, for example AUC0-2h of C-peptide at Week 54 Relative to Baseline, Cmax of C-peptide at Week 54 Relative to Baseline, AUC0-4h of Glucose at Week 54 Relative to Baseline, AUC0-2h of Glucose at Week 54 Relative to Baseline, Cmax of Glucose at Week 54 Relative to Baseline and Number of Treatment Emergent Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 308 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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