Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

This trial is conducted in Europe and North America.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 3 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 1 diabetes mellitus for at least 5 years. Candidate for islet cell transplantation based upon local accepted practice and guidelines.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: treatment with any anti-diabetic medication other than insulin including insulin pump within 4 weeks of trial start; any previous organ transplantation; A history of acute idiopathic or chronic pancreatitis.

How the Study Was Run

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

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 and investigator.

It started in 2012-03-21 with completion listed for 2013-06-03.

It ran at 16 sites in France (5), United States (4), Canada (2), Switzerland (2), United Kingdom (2) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant (time frame: At week 52 after initial transplantation).

It also tracked 5 secondary outcomes, for example Number of Hypoglycaemic Episodes, Proportion of Insulin-Independent Subjects, Change in Islet Cell Yield During Culture and Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 3 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.