Liraglutide in Adolescents With Type 1 Diabetes

What Was Tested

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

Type 1 diabetes is an autoimmune disease that is usually diagnosed before the age of 20.

Individuals with this disease are completely dependent on insulin for survival.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

Type 1 diabetes (T1DM) affects approximately 1:500 children and represents the major form of diabetes in the pediatric population (1).

Diagnosis of T1DM is based on symptoms consistent with hyperglycemia (polyuria, polydipsia, and weight loss) and elevated blood sugars.

Diagnosis of T1DM is confirmed by measuring serum autoantibodies against insulin and other beta-cell proteins.

Subcutaneous insulin is the mainstay of diabetes care; however, ability to achieve optimal glycemic control is impacted by multiple factors including diet, exercise, and psychosocial barriers.

Who Took Part

5 actual participants took part.

It was open to people of any sex aged from 15 years up to 21 years.

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

Examples of who could join: Diagnosis of Type 1 Diabetes Mellitus greater than 1 year. Insulin regimen - continuous subcutaneous insulin infusion with continuous glucose monitoring device.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: previous exposure to liraglutide; history of abdominal surgery; gastrointestinal reflux disease.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

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

It started in 2012-05 with completion listed for 2022-08-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Weekly Blood Glucose (time frame: Visit 1 (Before Liraglutide) at baseline (Day 0) vs. Visit 2 (After Liraglutide) on Day 7;).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Liraglutide in 5 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.