Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes

What Was Tested

The trial (early phase 1) is built around Liraglutide.

These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give.

The computer program then tells an insulin pump to deliver the insulin.

It had 1 arm (groups): Closed Loop Insulin Delivery (experimental).

The registry classes the interventions as device and drug.

Who Took Part

15 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Age 18-40 years. Duration of T1D ≥ 1 year. Treated with CSII for at least 3 months. Body weight \> 50 kg (to accommodate phlebotomy). Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct; history of hypoglycemic seizure within last 3 months; anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, bun) or elevated liver function tests.

How the Study Was Run

Design: single-group and open-label.

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 2013-02 with completion listed for 2015-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Peak Post-prandial Venous Glucose Levels (time frame: 48 hours).

It also tracked 1 secondary outcome, for example the Incremental Meal-related Glucose Area Under Curve (AUC).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Liraglutide in 15 people.

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

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.