Silva Arslanian, M.D. Richard L. Day Professor of Pediatrics Pediatric Endocrinology, Metabolism & Diabetes Mellitus University of Pittsburgh, School of Medicine Director, Pediatric Clinical & Translational Research Center Scientific Director, Center for Pediatric Research in Obesity & Metabolism Children's Hospital of Pittsburgh

If FDA Approved, Dulaglutide Provides New Treatment Option for Youth with Type 2 Diabetes

MedicalResearch.com Interview with:

Silva Arslanian, M.D. Richard L. Day Professor of Pediatrics Pediatric Endocrinology, Metabolism & Diabetes Mellitus University of Pittsburgh, School of Medicine Director, Pediatric Clinical & Translational Research Center Scientific Director, Center for Pediatric Research in Obesity & Metabolism Children's Hospital of Pittsburgh

Dr. Arslanian

Silva Arslanian, M.D.
Richard L. Day Professor of Pediatrics
Pediatric Endocrinology, Metabolism & Diabetes Mellitus
University of Pittsburgh, School of Medicine
Director, Pediatric Clinical & Translational Research Center
Scientific Director, Center for Pediatric Research in Obesity & Metabolism
Children’s Hospital of Pittsburgh

MedicalResearch.com:  What is the background for this study? 

Response: The lack of pharmacotherapeutic agents that target pathophysiological abnormalities in youth T2DM combined with the knowledge that glycemic failure rates to metformin, a recommended first-line therapy, are high in youth.

MedicalResearch.com:  What are the main findings?

1-In a DB, PC, 26-week trial of adolescents with T2DM (being treated with lifestyle modification alone or with metformin with or without basal insulin), 10<18 yrs. old with BMI >85th%, Dulaglutide showed superiority in improving HbA1C with the 0.75 and 1.5 mg weekly doses as well as the pooled-dose group. At 26 weeks, while HbA1C increased (+ 0.6%) in the placebo group, it decreased in the Dula groups (-0.6% in 0.75 mg dose group and -0.9% in the 1.5 mg dose group.
2– Similarly, Fasting plasma glucose concentrations improved with Dulaglutide.

3– Significantly more participants achieved an HbA1C <7% with Dulaglutide (51% in the Dula pooled group vs. 14% with placebo).

4– There were no differences among the groups in the change in BMI or other adiposity parameters.

MedicalResearch.com: What should readers take away from your report?

Response: If FDA approved, Dulaglutide provides a new treatment that showed efficacy and safety in youth with T2DM not well controlled with the current standard therapies. 

What recommendations do you have for future research as a result of this study? 

Response: To pursue the observation as to why there was no change in weight or BMI in these youth with T2DM unlike the adult trials.

Disclosures: Our center participated in this trial. 

Citation:

Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes

Silva A. Arslanian, M.D., Tamara Hannon, M.D., Philip Zeitler, M.D., Ph.D., Lily C. Chao, M.D., Claudia Boucher-Berry, M.D., Margarita Barrientos-Pérez, M.D., Elise Bismuth, M.D., Sergio Dib, M.D., Ph.D., Jang Ik Cho, Ph.D., and David Cox, Ph.D. for the AWARD-PEDS Investigators
June 4, 2022
DOI: 10.1056/NEJMoa2204601
https://www.nejm.org/doi/full/10.1056/NEJMoa2204601

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Last Updated on June 6, 2022 by Marie Benz MD FAAD