Transfusion Dependent Beta ThalassemiaPhase 2NCT07370922
Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia
A Phase 2 study testing Dulaglutide 0.75Mg/0.5Ml Inj Pen in people with Transfusion Dependent Beta Thalassemia, run by Ain Shams University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Transfusion Dependent Beta Thalassemia
- What is being tested?
- Dulaglutide 0.75Mg/0.5Ml Inj Pen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2024to 5 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to 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).
Who cannot join
- 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.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2).
- Intake of any vitamins or food supplements one month before study and participation in a previous investigational drug study within the three months preceding screening.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Transfusion Dependent Beta Thalassemia
- Being tested
- Dulaglutide 0.75Mg/0.5Ml Inj Pen, control group (insulin)
- Keywords
- GLP-1 receptor agonist, Dulaglutide, Diabetes, Transfusion Dependent Thalassemia
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dulaglutide 0.75Mg/0.5Ml Inj PenDrug
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 group | Role | What they receive |
|---|---|---|
| Dulaglutide group | Experimental | Not described Receives: Drug: Dulaglutide 0.75Mg/0.5Ml Inj Pen |
| Control group | Active comparator | Control group Receives: Drug: control group (insulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic variability using continuous glucose monitoring after 6 months.
Change in glycemic variability using continuous glucose monitoring after 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start22 Nov 2024
- Primary completion22 Nov 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transfusion Dependent Beta ThalassemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran yousef, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370922
- Sponsor's protocol ID
- FMASU MS 794/2024
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adly AAM, Ismail EAR, Abdel Kader MSEM, Sadeq MR, Salah NY. Dulaglutide vs insulin in adolescents with thalassaemia-induced diabetes: effect on metabolism and atherogenesis (DIADEMA). Diabetologia. 2026 Aug 19. doi: 10.1007/s00125-026-06835-x. Online ahead of print.
PubMed 42618811
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia
- ClinicalTrials.gov ID
- NCT07370922
- Acronym / sponsor ID
- FMASU MS 794/2024
- Conditions
- Transfusion Dependent Beta Thalassemia
- Keywords
- GLP-1 receptor agonist, Dulaglutide, Diabetes, Transfusion Dependent Thalassemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide group | Experimental | Drug: Dulaglutide 0.75Mg/0.5Ml Inj Pen |
| Control group | Active comparator | Drug: control group (insulin)Control group |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2).
- Intake of any vitamins or food supplements one month before study and participation in a previous investigational drug study within the three months preceding screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dulaglutide 0.75Mg/0.5Ml Inj PenDulaglutide subcutaneous injection in a dose of 0.75 mg once weekly for 6 months. | Drug | Dulaglutide group |
| control group (insulin)Insulin basal blocs according to guidelines | Drug | Control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Derived from this study: PubMed 42618811Adly AAM, Ismail EAR, Abdel Kader MSEM, Sadeq MR, Salah NY. Dulaglutide vs insulin in adolescents with thalassaemia-induced diabetes: effect on metabolism and atherogenesis (DIADEMA). Diabetologia. 2026 Aug 19. doi: 10.1007/s00125-026-06835-x. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dulaglutide 0.75Mg/0.5Ml Inj Pen in people with Transfusion Dependent Beta Thalassemia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic variability using continuous glucose monitoring after 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07370922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.