The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes

What Was Tested

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

This trial is conducted globally.

The total trial duration per subject is approximately 58 weeks.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (placebo comparator) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

1398 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: \- Informed consent obtained. \- Type 1 diabetes mellitus for 12 months or longer. \- Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer. \- Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: \- prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dpp-4) inhibitors; \- use of any medication, which in the investigator's opinion could interfere with the glycaemic control or affect the subject's safety.premix insulin is not allowed; \- known proliferative retinopathy or maculopathy requiring acute treatment.

How the Study Was Run

Design: 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.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2013-11 with completion listed for 2015-06.

It ran at 182 sites in United States (70), Canada (15), France (13), Germany (10), United Kingdom (10) and Finland (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 52). Change From Baseline in Body Weight (time frame: Week 0, week 52).

It also tracked 1 secondary outcome, for example Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 1398 people.

With 1398 participants it is a large trial for this field.

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.