Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Liraglutide.

It had three arms (groups): type 1 DM with betacell function: Liraglutide (experimental), type 1 DM without betacell function: Liraglutide (experimental) and type 1 DM without betacell function: Insulin (no intervention).

The registry classes the interventions as drug and other.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Type 1 diabetes diagnosed between age 5 and age 40,. No known diabetes complications or cardiovascular diseases,. No medication known to influence glucose homeostasis,.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: diabetes complications,; autonomous nerve dysfunction,; estimated by the investigator to be incapable of completing the trial.

How the Study Was Run

It was run as a randomized, single-group and open-label 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.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-10 with completion listed for 2010-10.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example 24-hours glucose profiles with and without treatment of Victoza, risk of hypoglycemia during physical activity with and without Victoza, gastric emptying rate during hypoglycemia with and without Victoza and weight change from baseline, change in fructosamine from baseline.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Liraglutide in 30 people.

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

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.