Dulaglutide vs insulin in adolescents with thalassaemia-induced diabetes: effect on metabolism and atherogenesis (DIADEMA)
Abstract
Aims/hypothesis: Chronic iron overload represents a significant morbidity in transfusion-dependent β-thalassaemia (TDT), leading to various complications, including diabetes and CVDs. The glucagon-like peptide-1 receptor agonist dulaglutide has been approved for the treatment of type 2 diabetes in paediatrics. In addition, it was recently approved for the treatment of CVDs. Hence, this study aimed to assess the effect of dulaglutide compared with conventional insulin therapy on glycaemic metrics, pancreatic reserve, iron load and dyslipidaemia among adolescents with TDT-induced diabetes.
Methods: The open-label, parallel-group, randomised-controlled DIADEMA trial took place at the Paediatric Haematology Unit and the Paediatric and Adolescent Diabetes Unit, Paediatrics Hospital, Ain Shams University, Cairo, Egypt. Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin. The 80 participants were randomly assigned based on a computer-generated randomisation sequence to receive either subcutaneous dulaglutide (0.75 mg weekly) or conventional basal-bolus insulin therapy. Participants were followed up for 24 weeks with assessment of fasting blood glucose, HbA1c, fructosamine, fasting C-peptide, continuous glucose monitoring (CGM)-derived metrics, haemolysis markers, serum ferritin and lipid profile. The primary efficacy endpoint was the change in the CV as an index for glycaemic variability from baseline to week 24. People…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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