Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus

What Was Tested

This registered phase 4 trial tested Insulin (regular human) and Liraglutide.

The purpose of this study is to investigate the therapeutic effect of Liraglutide on autoimmune diabetes.

It had two arms (groups): Liraglutide + insulin (experimental) and Insulin (active comparator).

Patients will receive insulin injection as a routine therapy.

The registry classes the interventions as drug.

More on the Plan

Autoimmune Diabetes Mellitus (AIDM) is a subtype of diabetes mellitus caused by autoimmune destruction of beta cells in the islet, including Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA).

However, its clinical application in AIDM is not well-defined so far.

The aim of this study is to investigate the potential use of Liraglutide on glycemic control in AIDM.

Who Took Part

The registry lists 20 planned participants were the target.

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 according to ADA criteria \<3 years. Age≥ 18 years. Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A. Written informed consent from the patient or family representative.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: history or family history of medullary thyroid carcinoma or men 2 syndrome;; history of chronic or acute pancreatitis;; allergic to liraglutide or any components in victoza®;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2017-01 with completion listed for 2020-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean amplitude of glycemic excursions (MAGE) (time frame: 1 year).

It also tracked 5 secondary outcomes, for example Change in HbA1C, Change in C-peptide, Hyperglycemic and hypoglycemic events and Life quality evaluation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Liraglutide in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Liraglutide compound page, all human trials.