# Dulaglutide vs Insulin in Adolescents With Thalassaemia-Related Diabetes > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/dulaglutide-thalassaemia-related-adolescent-diabetes-trial/ > **Published:** 2026-08-20T11:45:30-04:00 | **Last Modified / Clinically Audited:** 2026-09-27T22:00:21-04:00 > **Clinical Summary:** Explore dulaglutide in thalassaemia-related adolescent diabetes showing improved glucose variability over insulin in a 24-week trial of 80 adolescents. --- CED Clinical Relevance #82 [Clinical Evidence](https://cedclinic.com/academic-partnerships-cannabis-research/) Update A peer-reviewed randomized controlled trial directly compared weekly dulaglutide with basal-bolus insulin for 24 weeks in 80 adolescents with transfusion-dependent beta-thalassaemia and diabetes uncontrolled on metformin. Clinical Insight | CED Clinic Adly and colleagues randomized 80 adolescents with transfusion-dependent beta-thalassaemia and diabetes uncontrolled on metformin to weekly dulaglutide or basal-bolus insulin. Dulaglutide improved the primary glucose-variability measure and several secondary metabolic outcomes over 24 weeks. No serious adverse event was reported in the abstract, but that is not equivalent to a complete long-term safety assessment. The study is promising, yet its small single-center population, open-label treatment, short follow-up, rare-disease setting, and incomplete abstract-level adverse-event detail require caution. It supports larger multicenter trials and specialist discussion, not independent insulin withdrawal or broad pediatric prescribing conclusions. GLP-1DulaglutideAdolescent DiabetesThalassaemia[Randomized Trial](https://cedclinic.com/cannabis-cannabinoids-therapeutic-applications-review/) Audience Families affected by transfusion-dependent thalassaemia, pediatric endocrinologists, hematologists, diabetes clinicians, and readers following GLP-1 evidence Primary Topic dulaglutide versus insulin in adolescents with thalassaemia-related diabetes Source [Read the full source](https://pubmed.ncbi.nlm.nih.gov/42618811/) In an open-label [randomized trial](https://cedclinic.com/cannabis-cannabinoids-therapeutic-applications-review/) of 80 adolescents with transfusion-dependent beta-thalassaemia and diabetes, weekly dulaglutide improved glucose variability and several metabolic measures more than basal-bolus insulin over 24 weeks. The single-center, short-duration study was exploratory and does not establish long-term safety, cardiovascular benefit, or superiority for adolescents outside this rare clinical population. What This Study Teaches Us Dulaglutide reduced the continuous-glucose-monitoring coefficient of variation from 39.45% to 35.05%, while the insulin group’s value increased from 39.85% to 43.26%. The standardized between-group effect size was 1.69, with a 95% confidence interval from 1.16 to 2.22. Time in range, HbA1c, fasting glucose, fructosamine, C-peptide, total cholesterol, and ferritin also favored dulaglutide in the authors’ analyses. Why This Matters Diabetes in transfusion-dependent thalassaemia can reflect iron-related pancreatic injury and presents a specialized management problem. This trial is clinically meaningful because it tested a GLP-1 receptor agonist against active insulin treatment in adolescents, but its findings apply to a narrow population and need independent, longer-term confirmation. Study Snapshot Study Type Open-label, parallel-group randomized controlled trial with masked outcome assessment Population 80 adolescents aged 10 to 18 years with transfusion-dependent beta-thalassaemia and diabetes uncontrolled on metformin Setting Ain Shams University Paediatrics Hospital, Cairo, Egypt Intervention Dulaglutide 0.75 mg by subcutaneous injection once weekly Comparator Conventional basal-bolus insulin therapy Duration 24 weeks Primary Outcome Change in continuous-glucose-monitoring coefficient of variation, a measure of glycaemic variability Primary Result Coefficient of variation fell from 39.45% to 35.05% with dulaglutide and rose from 39.85% to 43.26% with insulin; standardized between-group effect size 1.69, 95% CI 1.16 to 2.22 Other Outcomes Time in range, time above range, fasting glucose, HbA1c, fructosamine, fasting C-peptide, total cholesterol, and ferritin Serious Adverse Events No serious adverse event was reported in the abstract Trial Registration ClinicalTrials.gov NCT07370922 Journal Diabetologia Published August 19, 2026 PMID / DOI 42618811 / 10.1007/s00125-026-06835-x Major Limitation Small, single-center, open-label, 24-week trial in a rare pediatric population Clinical Bottom Line Weekly dulaglutide produced better short-term glucose-variability and metabolic results than basal-bolus insulin in this 80-participant trial. The finding supports further study in thalassaemia-related diabetes, not a broad change in pediatric diabetes treatment or independent medication changes. The Primary Outcome Favored Dulaglutide The prespecified primary endpoint was glucose variability measured by the continuous-glucose-monitoring coefficient of variation. The direction and magnitude of the between-group result favored dulaglutide, but one modest-sized trial cannot establish durability or effectiveness across different centers. Several Metabolic Measures Also Improved The authors reported favorable changes in time in range, fasting glucose, HbA1c, fructosamine, fasting C-peptide, total cholesterol, and ferritin. These secondary findings are clinically interesting, but multiplicity, short follow-up, and the exploratory framing limit certainty. Safety Evidence Is Still Limited No serious adverse event was reported during the 24-week study. That does not prove an absence of hypoglycaemia, gastrointestinal effects, uncommon harms, or longer-term safety concerns. The abstract does not provide a complete event table. This Is a Highly Specific Population Participants had transfusion-dependent beta-thalassaemia and diabetes uncontrolled on metformin, not typical adolescent type 2 diabetes. Iron overload, pancreatic reserve, transfusion care, and chelation treatment may affect both risk and response, so generalization should be restrained. Active Comparison Adds Value and Complexity Comparing dulaglutide with basal-bolus insulin is more clinically informative than a placebo-only design. The open-label treatment assignment, different administration patterns, and single-center setting can influence adherence, co-interventions, and behavior even though outcome assessors were masked. How Strong Is This Evidence? Random assignment, an active comparator, continuous glucose monitoring, a prespecified variability endpoint, and masked outcome assessment strengthen the short-term comparison. Where This Paper Deserves Skepticism The trial included only 80 participants at one center, treatment was open-label, follow-up lasted 24 weeks, the population was unusually specific, and the abstract provides incomplete adverse-event detail. What This Paper Does Not Show The trial does not establish long-term glycaemic durability, prevention of cardiovascular or microvascular complications, reduced mortality, superiority in ordinary type 1 or type 2 diabetes, safety in other pediatric populations, or that insulin can be stopped without specialist supervision. How This Fits With the Broader Clinical Conversation Thalassaemia-related diabetes is shaped by iron overload, pancreatic injury, transfusion exposure, and the broader endocrine complications of chronic disease. For patients and families, the practical question is not whether GLP-1 therapy is universally better than insulin. It is whether the treatment fits the individual diagnosis, pancreatic reserve, glucose pattern, nutritional status, adverse-effect risk, and hematology plan. Dr. Caplan’s Take *I read this as a promising randomized signal in a rare and clinically difficult population. The glucose-variability result is meaningful, but 24 weeks is a beginning rather than a treatment verdict.* *No adolescent should change insulin or begin dulaglutide because of one paper. Any application would require coordinated pediatric endocrinology and hematology care, with close glucose and nutrition monitoring.* What a Careful Reader Should Take Away A careful reader should conclude that dulaglutide outperformed basal-bolus insulin on short-term glucose variability and several secondary measures in this specific trial, while recognizing that larger multicenter studies are needed before practice changes. Evidence Interpretation Guide Table of Contents - [How to Read an Active-Comparator Trial in a Rare Pediatric Population](#How_to_Read_an_Active-Comparator_Trial_in_a_Rare_Pediatric_Population)[Four distinctions that matter](#Four_distinctions_that_matter) - [The Same Study Can Mean Different Things Depending on the Question Being Asked](#The_Same_Study_Can_Mean_Different_Things_Depending_on_the_Question_Being_Asked)[Do Not Change Insulin Independently](#Do_Not_Change_Insulin_Independently) - [Glucose Variability Was the Primary Endpoint](#Glucose_Variability_Was_the_Primary_Endpoint) - [Eighty Participants Is Still Small](#Eighty_Participants_Is_Still_Small) - [Open-Label Treatment Can Influence Care](#Open-Label_Treatment_Can_Influence_Care) - [A Rare-Disease Extension](#A_Rare-Disease_Extension) - [The Hematology Context Matters](#The_Hematology_Context_Matters) - [Longer Multicenter Follow-Up](#Longer_Multicenter_Follow-Up) - [Avoid Broad Pediatric Claims](#Avoid_Broad_Pediatric_Claims) - [Frequently Asked Questions](#Frequently_Asked_Questions)[Related](#Related) ## How to Read an Active-Comparator Trial in a Rare Pediatric Population The design is stronger than an uncontrolled report. The population and follow-up still sharply limit generalization. ### Four distinctions that matter **Variability versus average glucose**The primary endpoint was glucose variability, while HbA1c and other metabolic measures were secondary. **Dulaglutide versus insulin**An active comparison is clinically useful, but it does not mean insulin is unnecessary for every participant or population. **Masked assessment versus open treatment**Outcome assessors were masked, while patients and clinicians knew the assigned treatment. **Short-term signal versus practice standard**Twenty-four weeks can identify a promising effect but cannot establish long-term safety or complication prevention. The Research Question Can weekly dulaglutide improve glycaemic variability and metabolic measures compared with basal-bolus insulin in adolescents with thalassaemia-related diabetes? The Patient Question Does this result mean dulaglutide should replace my insulin? The Bottom Line The trial supports further study and specialist discussion, not independent treatment changes. CED Perspective Lens ## The Same Study Can Mean Different Things Depending on the Question Being Asked Scientific papers rarely answer a single question. Patients, clinicians, researchers, policymakers, and critics often read the same data differently. The perspectives below explore how this study looks through several evidence-based lenses. Lens Overview Eight perspectives separate a promising rare-disease randomized signal from the unanswered questions about safety, durability, and generalizability. #### Do Not Change Insulin Independently This trial does not support stopping insulin or starting dulaglutide without specialist care. The interpretation should remain matched to this 24-week [randomized trial](https://cedclinic.com/cannabis-cannabinoids-therapeutic-applications-review/). Lens takeaway Medication changes require coordinated pediatric endocrinology and hematology review. #### Glucose Variability Was the Primary Endpoint The main result concerns continuous-glucose-monitoring variability, with multiple secondary metabolic signals. The interpretation should remain matched to this 24-week randomized trial. Lens takeaway Keep the outcome hierarchy visible. #### Eighty Participants Is Still Small A large standardized effect can change in a broader multicenter replication. The interpretation should remain matched to this 24-week randomized trial. Lens takeaway Precision and reproducibility matter more than a dramatic estimate. #### Open-Label Treatment Can Influence Care Outcome assessors were masked, but participants and treating teams knew the assignment. The interpretation should remain matched to this 24-week randomized trial. Lens takeaway Behavioral and treatment-management differences remain possible. #### A Rare-Disease Extension This study moves pediatric dulaglutide research into thalassaemia-related diabetes rather than ordinary youth type 2 diabetes. The interpretation should remain matched to this 24-week randomized trial. Lens takeaway Population differences prevent simple extrapolation. #### The Hematology Context Matters Ferritin, chelation, transfusion history, pancreatic reserve, nutrition, and glucose patterns all shape interpretation. The interpretation should remain matched to this 24-week randomized trial. Lens takeaway Treatment belongs inside coordinated specialty care. #### Longer Multicenter Follow-Up Future trials should test durability, complete safety outcomes, hypoglycaemia, iron measures, [quality of life](https://cedclinic.com/cannabis-policy-enforcement-february-26-2026/), and clinical complications. The interpretation should remain matched to this 24-week randomized trial. Lens takeaway Replication should include more sites and longer follow-up. #### Avoid Broad Pediatric Claims A rare-disease trial should not be marketed as proof for all adolescents with diabetes. The interpretation should remain matched to this 24-week randomized trial. Lens takeaway Accurate population labeling protects families and clinicians. Join the Conversation Have a question about how this applies to your situation? [Ask Dr. Caplan](https://benjamincaplan.com/ask-dr-caplan) Want to discuss this topic with other patients and caregivers? [Join the forum discussion](https://cedclinic.com/interact/discussion-forums/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Physician-Led, Whole-Person Care A doctor who takes the time to truly understand you. Personal care that starts with listening and is guided by experience and ingenuity. Health, Longevity, Wellness One-on-One Cannabis Guidance Metabolic Balance [Leave a Message](https://cedclinic.com/contact/) [Metabolic Care](https://cedclinic.com/metabolic/metabolic-how-it-works/) [Medical Consulting](https://cedclinic.com/book/) [Cannabis Care](https://cedclinic.com/book/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Share this Evidence Watch [X](https://twitter.com/intent/tweet?text=Dulaglutide+vs+Insulin+in+Adolescents+With+Thalassaemia-Related+Diabetes&url=https%3A%2F%2Fcedclinic.com%2Fdulaglutide-insulin-thalassaemia-adolescent-diabetes-trial%2F) [LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A%2F%2Fcedclinic.com%2Fdulaglutide-insulin-thalassaemia-adolescent-diabetes-trial%2F) [BlueSky](https://bsky.app/intent/compose?text=Dulaglutide+vs+Insulin+in+Adolescents+With+Thalassaemia-Related+Diabetes%20https%3A%2F%2Fcedclinic.com%2Fdulaglutide-insulin-thalassaemia-adolescent-diabetes-trial%2F) [Instagram](https://www.instagram.com/drcaplan/) [Substack](https://doctorapprovedcannabis.substack.com/) [RSS](https://cedclinic.com/feed/) Source: [Dulaglutide vs insulin in adolescents with thalassaemia-induced diabetes: effect on metabolism and atherogenesis (DIADEMA).](https://pubmed.ncbi.nlm.nih.gov/42618811/) Related Reading at CED Clinic Continue exploring the evidence [GLP-1 Receptor Agonist Clinical Evidence in Pediatric Diabetes](https://cedclinic.com/oral-semaglutide-pediatric-diabetes-clinical-evidence/) Related pediatric evidence and the limits of extending findings across GLP-1 medicines. [Review pediatric GLP-1 evidence](https://cedclinic.com/oral-semaglutide-pediatric-diabetes-clinical-evidence/) [GLP-1 Receptor Agonist Safety: Clinical Trial Evidence](https://cedclinic.com/glp-1-receptor-agonist-pediatric-safety-clinical-evidence/) [Clinical context](https://cedclinic.com/cannabis-hyperemesis-syndrome-treatment-insights-2026/) for interpreting pediatric GLP-1 safety and trial duration. [Read the safety evidence](https://cedclinic.com/glp-1-receptor-agonist-pediatric-safety-clinical-evidence/) [GLP-1 Drugs: Clinical Evidence Beyond Weight](https://cedclinic.com/glp-1-receptor-agonists-metabolic-benefits/) A broader review of metabolic outcomes beyond weight loss. [Explore metabolic evidence](https://cedclinic.com/glp-1-receptor-agonists-metabolic-benefits/) ## Frequently Asked Questions What did the DIADEMA trial test? It compared weekly dulaglutide with conventional basal-bolus insulin for 24 weeks in adolescents with transfusion-dependent beta-thalassaemia and diabetes uncontrolled on metformin. How many adolescents participated? Eighty participants aged 10 to 18 years were randomized at Ain Shams University in Cairo, Egypt. What was the primary outcome? The primary endpoint was change in the continuous-glucose-monitoring coefficient of variation, a measure of glucose variability. What happened to glucose variability? It decreased from 39.45% to 35.05% with dulaglutide and increased from 39.85% to 43.26% with insulin. The standardized between-group effect size was 1.69, with a 95% confidence interval from 1.16 to 2.22. Which other outcomes favored dulaglutide? The authors reported favorable changes in time in range, time above range, fasting glucose, HbA1c, fructosamine, fasting C-peptide, total cholesterol, and ferritin. Were serious adverse events reported? The abstract reports no serious adverse event, but it does not provide a complete adverse-event table and 24 weeks is too short to define uncommon or long-term harms. Does the trial prove dulaglutide is safer than insulin? No. The trial was small and short, and the available abstract does not support a broad [comparative safety](https://cedclinic.com/comparative-harm-assessments-cannabis-canadian-study/) conclusion. Can the findings be applied to ordinary adolescent type 2 diabetes? Not directly. Participants had diabetes associated with transfusion-dependent beta-thalassaemia, a rare condition with distinct iron, pancreatic, transfusion, and treatment factors. Should patients stop insulin after reading this study? No. Insulin or GLP-1 treatment changes require individualized supervision from pediatric endocrinology and hematology clinicians. What research is needed next? Larger multicenter trials with longer follow-up, complete adverse-event reporting, and patient-important clinical outcomes are needed. ### Related --- ### Verification & Medical Governance - **Lead Clinical Author:** Benjamin Caplan, MD - **Credentials:** Board Certified in Family Medicine (ABFM), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House). - **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`). - **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/). - **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637). - **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).