Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia

What Was Tested

The trial (phase 2) is built around Dulaglutide.

It had two arms (groups): Dulaglutide group (experimental) and Control group (active comparator).

Control group.

The registry classes the interventions as drug.

Who Took Part

The registry lists 80 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

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

Examples of who could join: Age 10-18 years old. Children with TDT according to the Thalassemia International Federation (TIF) guidelines (Farmakis et al., 2022). Children with diabetes mellitus according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) 2022 guidelines (Libman et al., 2022).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: other hemoglobinopathies as alpha thalassemia or sickle thalassemia patients; other disorders that may affect glucose homeostasis rather than β-tm; autoimmune disease, collagen diseases, hypo- or hyper-thyroidism, infections, tumors, hematological diseases other than β-tm.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Dulaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Only one side, usually the participants, was kept unaware of whether Dulaglutide was given.

Those kept unaware of assignments: participant.

It started in 2024-11-22 with completion listed for 2025-11-22.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in glycemic variability using continuous glucose monitoring after 6 months (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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