Golimumab (GLM) Preserves ß-Cell Function and Reduces Insulin Use in Children and Young Adults with Recently Diagnosed Type 1 Diabetes (T1D): The Phase 2 T1GER Study

Teresa Quattrin, MD

ADA 2020 - Poster session

4 minute listen
2 minute read

Key messages

  • In this phase 2a study in children and young adults with newly diagnosed stage 3 T1D, golimumab preserved endogenous insulin production and reduced exogenous insulin requirements.
  • Both groups had good treat-to-target glycemic control, and the change from baseline in HbA1c did not differ significantly between groups.
  • In a post hoc analysis, ADA Level 2 hypoglycemic episodes (BG <54 mg/dL) were lower in the pediatric population.
  • Compared to placebo, the golimumab group had a higher percentage of participants with C-peptide increase or minimal loss and were in partial remission while experiencing little or no increase in proinsulin/C-peptide ratio over time. These findings suggest that golimumab may be arresting disease progression for a large subset of patients
  • This study used a novel T1D-specific dosing regimen for golimumab, which had a favorable safety profile consistent with regimens used previously, without any serious infections in either group.
  • These results support golimumab as a potential disease-modifying therapy for T1D.
  • Podcast by Teresa Quattrin, MD

Key messages

  • In this phase 2a study in children and young adults with newly diagnosed stage 3 T1D, golimumab preserved endogenous insulin production and reduced exogenous insulin requirements.
  • Both groups had good treat-to-target glycemic control, and the change from baseline in HbA1c did not differ significantly between groups.
  • In a post hoc analysis, ADA Level 2 hypoglycemic episodes (BG <54 mg/dL) were lower in the pediatric population.
  • Compared to placebo, the golimumab group had a higher percentage of participants with C-peptide increase or minimal loss and were in partial remission while experiencing little or no increase in proinsulin/C-peptide ratio over time. These findings suggest that golimumab may be arresting disease progression for a large subset of patients
  • This study used a novel T1D-specific dosing regimen for golimumab, which had a favorable safety profile consistent with regimens used previously, without any serious infections in either group.
  • These results support golimumab as a potential disease-modifying therapy for T1D.

Podcast by Teresa Quattrin, MD

 

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. 

Consultant: Janssen Research & Development

Clinical Trial, Principal Investigator at the Buffalo site: Janssen, Provention Bio, Inc., OPKO Biologics Ltd., and Ascendi



Diabetes
Type 1 Diabetes


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