Liraglutide in the Treatment of Type 1 Diabetes Mellitus

What Was Tested

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

It had four arms (groups): Placebo (placebo comparator), one (active comparator), one (active comparator) and one (active comparator).

Daily Injection.

Daily Injection.

Daily injections.

The registry classes the interventions as drug.

More on the Plan

RESEARCH DESIGN AND METHODS This investigation will be a prospective, randomized, double blind, placebo controlled study conducted in type 1 diabetics.

Study Population: Seventy two patients with type 1 diabetes on treatment with either continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day will be included in the study.

They will be randomized into 4 groups of 18 patients each.

Subjects will be recruited from their own patients, their existing database and from advertisements.

Who Took Part

The registry lists 72 actual participants took part.

It was open to women only aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Using a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily. Well versed with carbohydrate counting. Age 18-75 years.

The full record lists 5 inclusion and 15 exclusion criteria; among the exclusions: type 1 diabetes for less than 12 months;; coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks;; hepatic disease (transaminase \> 3 times normal) or cirrhosis;.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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, care provider and investigator.

It started in 2012-11-01 with completion listed for 2014-04-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Mean Weekly Glucose Concentrations (time frame: 12 Weeks).

It also tracked 6 secondary outcomes, for example Change in HbA1c, Change in Body Weight From Baseline, Change in the Area Under Curve (AUC) of Glucose Following the Meal, Change in Carbohydrate Intake and Change in Glucagon Concentrations.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 72 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.