Liraglutide in Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Liraglutide.

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

Daily Injection.

Daily Injection.

The registry classes the interventions as drug.

More on the Plan

Furthermore, in the near total absence of insulin secretion, the physiological post prandial inhibition of glucagon secretion by the α-cell is also probably deficient in all type 1 diabetics.

Since C-peptide concentrations did not alter following Liraglutide, it is likely that the suppression of glucagon may have contributed to this effect.

Who Took Part

Enrollment: 69 actual participants took part.

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

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

Examples of who could join: Regularly measuring blood sugars four times daily. Well versed with carbohydrate counting. Age 18-75 years. BMI 20-40 kg/m2.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: 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;; HIV or Hepatitis B or C positive status;.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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, care provider and investigator.

It started in 2012-11-01 with completion listed for 2019-01-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (%) (time frame: 52 Weeks).

It also tracked 2 secondary outcomes, for example Mean Weekly Glucose Concentrations and Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 69 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.