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

Sponsor
Ain Shams University
Study ID
NCT07370922
Phase
PHASE2
Status
Completed

Conditions

  • Transfusion Dependent Beta Thalassemia

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide 0.75Mg/0.5Ml Inj Pen — DRUG
    Dulaglutide subcutaneous injection in a dose of 0.75 mg once weekly for 6 months.
  • control group (insulin) — DRUG
    Insulin basal blocs according to guidelines

Study Details

Blood transfusion and iron-chelation therapy have prolonged and improved the quality of life in patients with β-thalassemia. The improvement was mainly due to the decrease in mortality from heart failure Such a treatment, however, leads to chronic iron overload and frequently to endocrine complications, especially the development of diabetes. The prevalence of diabetes mellitus (DM) in β-thalassemia varies from 9.7% to 29% and the overall prevalence of impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) is 17.2% and 12.4% respectively in transfusion dependent thalassemia (TDT) patients. GLP-1 is a proglucagon derived peptide that is released from gut endocrine cells in response to nutrient intake. This molecule is rapidly inactivated by the action of dipeptidyl peptidase IV (DPP-4) which limits its use as therapeutic agent. Recent guidelines by the American Diabetes Association and the European Association for the Study of Diabetes recommend that for patients with type 2 diabetes, GLP-1 receptor agonists (GLP-1RAs) are preferable to insulin as the initial injection therapy and are also the preferred choice for addition to basal insulin for combination injection therapy. An increasing number of clinical trials of agents in youth-onset T2D resulted in the availability of more efficacy data and regulatory approval for two Glucagon-like peptide-1 (GLP-1) receptor agonists (Liraglutide and Exenatide) in Pediatrics. The Efficacy of the daily GLP-1 agonist, Liraglutide, in youth-onset T2D wasstudied in the Ellipse trial, which demonstrated placebo-subtracted. HbA1c lowering of 1% and 1.5% at 26 and 52 weeks, respectively. This glycemic reduction was accompanied by a small decrease in BMI z-score. Liraglutide (Victoza 0.6-1.8 mg a day) subsequently received approval by the FDA for use in youth 12-17 years of age. Recently, extended release exenatide (Bydureon BCise 2 mg) was approved as a once-weekly injection for youth 10-17 years of age based on data from the BCB114 study showing superiority to placebo in lowering HbA1c with a between-group difference of 0.85 percentage points. Hence, the aim of this study is to assess the efficacy and safety of GLP-1 receptor agonist versus conventional insulin therapy in the management of diabetes mellitus in children with transfusion -dependent Thalassemia.

Key Dates

Start date
Nov 22, 2024
Status verified
Jan 2026
Primary completion
Nov 22, 2025
Completion
Jan 5, 2026

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dulaglutide group
  • Active Comparator: Control group
    Control group

Primary Outcome Measure

Change in glycemic variability using continuous glucose monitoring after 6 months. [ Time Frame: 6 months ]

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