戈利木单抗（GLM）在新诊T1D儿童及青少年中可保持ß细胞功能并减少胰岛素用量（2期T1GER研究）
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关键信息
- 在针对新诊断1型糖尿病（T1D）的儿童和青少年的2a期研究中，戈利木单抗可保持内源性胰岛素产生并减少外源性胰岛素需求。
- 两组均实现了以达标为目的的血糖控制，且两组间HbA1c较基线的变化无明显差异。
- 事后分析显示，儿童人群中ADA 2级低血糖（BG <54 mg / dL）发生率较低。
- 与安慰剂相比，戈利木单抗组C肽增加或最小比例丢失，呈部分性缓解，而胰岛素原/ C肽比例随时间推移没有或很少增加。这些发现表明，戈利木单抗可能会阻止大部分患者的疾病进展。
- 这项研究在TID患者中使用了一种新的戈利木单抗给药方案，具有与以前使用方案一致的安全性，两组均无严重感染。
- 这些结果支持戈利木单抗作为T1D的潜在疾病缓解疗法。
Presenting Author
Teresa Quattrin, MD
Jacobs School of Medicine and Biomedical Sciences
University at Buffalo and JR Oishei Children's Hospital Diabetes Center
Dr. Teresa Quattrin is a Pediatric Endocrinologist and Diabetologist who founded the Diabetes Center of the Women and Children’s Hospital of Buffalo (now the John R. Oishei Children’s Hospital) in 1990 and quickly established it as a top US clinical research center. The center conducts pivotal trials on novel therapies and new technologies in Type 1 diabetes and other endocrine disorders. During her leadership the Diabetes Center has received grant funding and designation from the New York State Department of Health as New York State Center of Excellence for Type 2 Diabetes.
In 2010 she was appointed Chair of the Department of Pediatrics, Pediatrician in Chief of the Oishei Children’s Hospital, Chief of Pediatrics Service for Kaleida Health and President and CEO of UBMD Pediatrics. She played a key role in fundraising and planning for the new Oishei Children’s Hospital that opened in 2017. She was also instrumental in launching the joint venture in Pediatric Oncology and Hematology between Oishei Children’s Hospital and the Roswell Park Comprehensive Cancer Center, as well as other programs.
In 2016, her dedication to increasing the participation of families, children and underrepresented populations in clinical trials led her to assume the role of Director, Special Populations Core in the Clinical and Translational Scientific Institute at UB.
In 2018, she assumed the inaugural role of Senior Associate Dean for Research Integration in the Jacobs School. In this role, she promotes integrated, collaborative research within the medical school and with other colleges and partners across and outside of UB, including community stakeholders.
Dr. Quattrin is an internationally renowned physician-scientist with expertise in childhood diabetes and obesity. She has received a continuous stream of funding from federal and state agencies, pharmaceutical sponsors and foundations to pursue clinical research in diabetes and obesity and conduct clinical trials on preventing or halting Type 1 diabetes progression. She serves as a reviewer for several high impact national and international journals, the National Institutes of Health, the Diabetes Research Office of the United Kingdom, the Diabetes Clinical Trials Network in Ireland and the Italian Ministry of Health.
Quattrin is a member of many prestigious societies, including the American Diabetes Association, the Pediatric Endocrinology Society, The Endocrine Society, the Society for Pediatric Research, Pediatric Academic Society, the American Academy of Pediatrics, the Association for Clinical and Translational Science and the Association of Medical School Pediatric Department Chairs (emeritus member).
Throughout her career, Dr. Quattrin has been recognized for her passion for innovation and clinical-translational research. She was named numerous times among the “Best Doctors in America,” for her excellence in patient care. Her service and administrative skills were recognized by her election to the Board of Directors of the American Association of Pediatric Chairs.
Disclosures
Consultant: Janssen Research & Development
Clinical Trial, Principal Investigator at the Buffalo site: Janssen, Provention Bio, Inc., OPKO Biologics Ltd., and Ascendi
