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Study · Randomized controlled trial · n = 80 · 2026

10 results

Dulaglutide vs insulin in adolescents with thalassaemia-induced diabetes: effect on metabolism and atherogenesis (DIADEMA).

Adly AAM, Ismail EAR, Abdel Kader MSEM, Sadeq MR, Salah NY

Diabetologia19 Aug 2026

Summary

Aims/hypothesisChronic 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.MethodsThe 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 assessing the outcomes were masked (blind) to group assignment.ResultsBoth groups were similar as regards baseline clinico-laboratory characteristics (p>0.05). After 24 weeks, dulaglutide resulted in a significant decrease in CV (from 39.45 ± 3.97% to 35.05 ± 4.30%; p<0.001), time above range, fasting blood glucose, HbA1c, fructosamine, total cholesterol and serum ferritin, with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05). Although the glucose management indicator decreased in the insulin group after 24 weeks compared with baseline, the CV (from 39.85 ± 4.99% to 43.26 ± 5.75%; p<0.001) and time above range were significantly increased (p<0.001). The estimated standardised effect size for the between-group difference in the CV was 1.69 (95% CI 1.16, 2.22). No serious adverse event was reported.Conclusions/interpretationThe glucagon-like peptide-1 receptor agonist dulaglutide therapy was associated with greater improvements in glycaemic control and variability compared with insulin among adolescents with TDT-induced diabetes, without risk of hypoglycaemia or compromising safety. Moreover, dulaglutide might have a beneficial effect on iron overload, insulin secretion and lipid profile. These findings are exploratory and clinically provocative, warranting further investigation.FundingThis research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.Trial registrationClinicalTrials.gov NCT07370922.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide reduced glycemic variability versus baseline and insulin.

    In plain wordsDulaglutide reduced blood sugar variability versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    DecreaseGlycemic variability CV
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Coefficient of variation (CV)
    39.45%
    dulaglutide group, baseline
    Coefficient of variation (CV)
    35.05%
    dulaglutide group, week 24
    Coefficient of variation (CV)
    39.85%
    insulin group, baseline
    Coefficient of variation (CV)
    43.26%
    insulin group, week 24
    Standardised effect size
    1.69 effect size
    between-group difference in CV

    Source sentences

    Summary
    After 24 weeks, dulaglutide resulted in a significant decrease in CV (from 39.45 ± 3.97% to 35.05 ± 4.30%; p<0.001)
    5 context sentences
    Summary · context
    compared with baseline levels and with the insulin group (p<0.05).
    Summary · context
    The estimated standardised effect size for the between-group difference in the CV was 1.69 (95% CI 1.16, 2.22).
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
    Summary · context
    Although the glucose management indicator decreased in the insulin group after 24 weeks compared with baseline, the CV (from 39.85 ± 4.99% to 43.26 ± 5.75%; p<0.001) and time above range were significantly increased (p<0.001).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide reduced time above range versus baseline and insulin.

    In plain wordsDulaglutide reduced time above the blood sugar target versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    DecreaseTime above range
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    time above range, fasting blood glucose, HbA1c, fructosamine, total cholesterol and serum ferritin, with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05).
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide reduced fasting glucose versus baseline and insulin.

    In plain wordsDulaglutide reduced fasting blood sugar versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    DecreaseFasting blood glucose
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    time above range, fasting blood glucose, HbA1c, fructosamine, total cholesterol and serum ferritin, with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05).
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide reduced HbA1c versus baseline and insulin.

    In plain wordsDulaglutide reduced HbA1c versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    DecreaseHbA1c
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    time above range, fasting blood glucose, HbA1c, fructosamine, total cholesterol and serum ferritin, with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05).
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide reduced fructosamine versus baseline and insulin.

    In plain wordsDulaglutide reduced fructosamine versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    DecreaseFructosamine
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    time above range, fasting blood glucose, HbA1c, fructosamine, total cholesterol and serum ferritin, with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05).
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide reduced total cholesterol versus baseline and insulin.

    In plain wordsDulaglutide reduced total cholesterol versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    DecreaseTotal cholesterol
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    time above range, fasting blood glucose, HbA1c, fructosamine, total cholesterol and serum ferritin, with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05).
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide reduced serum ferritin versus baseline and insulin.

    In plain wordsDulaglutide reduced serum ferritin versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    DecreaseSerum ferritin
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Outcome group
    Blood biochemical markers · Whole body
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    time above range, fasting blood glucose, HbA1c, fructosamine, total cholesterol and serum ferritin, with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05).
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide increased fasting C-peptide versus baseline and insulin.

    In plain wordsDulaglutide increased fasting C-peptide versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    IncreaseFasting C-peptide
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05).
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In adolescents with thalassaemia-induced diabetes, dulaglutide increased time in range versus baseline and insulin.

    In plain wordsDulaglutide increased time within the blood sugar target versus baseline and insulin in adolescents with thalassaemia-induced diabetes.

    Outcome
    IncreaseTime in range
    Study

    n = 80

    Comparator
    Conventional basal-bolus insulin
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    with a significant increase in fasting C-peptide and time in range compared with baseline levels and with the insulin group (p<0.05).
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.
  10. 10HumanRandomized controlled trialSafety outcome

    No serious adverse event was reported in the trial of dulaglutide versus insulin in adolescents with thalassaemia-induced diabetes.

    In plain wordsThe trial of dulaglutide versus insulin reported no serious adverse event in adolescents with thalassaemia-induced diabetes.

    Outcome
    Not applicableSerious adverse events
    Study

    n = 80

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.75 mg weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    No serious adverse event was reported.
    2 context sentences
    Summary · context
    Eligibility criteria were adolescents with TDT-induced diabetes aged 10-18 years, uncontrolled on metformin.
    Summary · context
    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.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT07370922

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

Ain Shams Universityn = 8022 Nov 2024 to 5 Jan 2026

Transfusion Dependent Beta Thalassemia

Trial pageClinicalTrials.govUpdated 27 Jan 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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