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

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted in Africa, Europe and North America.

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

The registry lists 835 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 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. Male or female, aged equal to or greater than 18 years at the time of signing informed consent. Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit 1 (i.e. screening). Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin pump) treatment 6 months or longer prior to Visit 1 (i.e. screening). Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as judged and documented by the investigator.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: prior use of glucagon-like peptide-1 (glp-1) receptor agonist or dipeptidyl peptidase iv (dppiv) inhibitors; known proliferative retinopathy or maculopathy requiring acute treatment; severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind 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.

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 2014-05 with completion listed for 2015-04.

It ran at 120 sites in United States (47), Belgium (10), France (10), Canada (9), Italy (8) and Finland (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 26).

It also tracked 2 secondary outcomes, for example Change From Baseline in Body Weight and 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 835 people.

With 835 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.