LIraglutide and Beta-cell RepAir (LIBRA) Study

What Was Tested

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

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body).

The researchers propose a double-blind, randomized controlled study comparing the effect of liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM.

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

The registry classes the interventions as drug.

More on the Plan

In this study, patients with type 2 diabetes who meet randomization criteria will be randomized to either liraglutide or placebo, with serial assessment of beta-cell function over 48 weeks follow-up.

The hypothesis under study is whether liraglutide can preserve beta-cell function.

Who Took Part

Enrollment: 63 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Men and women between the ages of 30 and 75 years inclusive. Physician-diagnosed type 2 diabetes of \</= 7 years duration. Negative for anti-GAD antibodies. On 0-2 oral anti-diabetic medications.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: use of insulin, glp-1 agonist, or dipeptidyl peptidase-4 (dpp-4) inhibitor; type 1 diabetes or secondary forms of diabetes; major illness with life expectancy \< 5 years.

How the Study Was Run

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

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.

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 2011-01 with completion listed for 2013-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2) (time frame: 48-weeks).

It also tracked 1 secondary outcome, for example Glycemic Control.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 63 people.

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.