TYPE 1 DIABETES: SIMPONI® TO ARREST Β-CELL LOSS IN TYPE 1 DIABETES (“T1GER”)
Protocol Title: SIMPONI® TO ARREST B-CELL LOSS IN TYPE 1 DIABETES
Investigational Product: Simponi® (golimumab)
Study Sponsors: Janssen Research & Development
Principal Investigator: Stephen E. Gitelman, MD
What is this study about? This study will evaluate whether golimumab administered subcutaneously (SC) in children and young adults ages 6 to 21 with newly diagnosed T1D has the potential to maintain residual β-cell function and improve metabolic control.
Who can sign up for this study? Participants must be 6 to 21 years old and have been diagnosed with type 1 diabetes mellitus (T1DM) within the past 100 days.
In addition, participants cannot have any of the following conditions:
- No active infection
- No history of renal, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic or psychiatric disease
- No history of liver disease
- No history of autoimmune diseases or nervous system disorders
- No pregnancy or breastfeeding
What will happen in this study? All volunteers will undergo a screening visit where they will discuss their medical history, undergo a physical exam, and provide blood and urine for labwork. As part of this screening visit, volunteers will also have a 4-hour Mixed Meal Tolerance Test. Individuals who meet eligibility criteria may choose to be be enrolled in the study. Participants will be randomly assigned to either study drug or placebo. You cannot choose which group you will be in and neither you nor the study team will know which group you are in. Participants will inject the study drug golimumab/placebo subcutaneously once every two weeks for a total of 52 weeks.
Participants will come to the hospital for study visits 14 times over the duration of the study. Participants will have a physical at each study visit, and will provide blood and urine for labwork at each visit. Additionally, there will be seven, 4-hour MMTTs performed over the course of the study.
Additional Study Info: www.t1gerstudy.com
How long will this study last? The study lasts for 2 years
Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time and travel expenses.
For more information please contact: UCSF Pediatric Endocrinology Type 1 Diabetes Clinical Research Team, phone: 844-813-8273 (toll-free) or email firstname.lastname@example.org