Trial · Interventional
CompletedPhase 2Registry dataEgypt
1 trial · 1 completed
Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia
NCT0737092222 Nov 2024 to 5 Jan 2026
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Dulaglutide group
Active comparator
Control group
Control group
Outcomes the sponsor listed as primary.
Change in glycemic variability using continuous glucose monitoring after 6 months.
Time frame · 6 months
Change in glycemic variability using continuous glucose monitoring after 6 months.
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No results are posted for this trial.
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Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2026
Adly et al. 2026Diabetologia
PMID 42618811PMC13627196DOI 10.1007/s00125-026-06835-xPUB-42618811
Who could join, as posted.
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