TYPE 1 DIABETES: AGE 6-17 YEARS WITHIN 3 MONTHS OF DIAGNOSIS

DRUG NAME: TOCILIZUMAB (ACTEMRA®)

 

Study Name: EXTEND-Preserving Beta-Cell Function with Tocilizumab in New-onset Type1 Diabetes

Study Sponsors: National Institute of Allergy and Infectious Diseases (NIAID)

Principal Investigator: Stephen E. Gitelman, MD, Chief-Pediatric Endocrinology, UCSF

Who can sign up for this study? Individuals aged 6-17 diagnosed with Type 1 Diabetes within the last three months.

 In addition, the volunteers may NOT have:

  •  Active infections
  •  Current or prior (within last 30 days) use of drugs other than insulin to treat hyperglycemia
  •  Pregnant, lactating, or planning pregnancy during the 2-year study period

What is this study about? The purpose of the study is to determine whether tocilizumab (Actemra ®) can protect the remaining insulin-producing beta cells in individuals newly diagnosed with type 1 diabetes.

What will happen in this study? All volunteers will undergo a screening visit which includes blood and urine samples, medical history and a physical exam to determine eligibility for study treatment. Eligible participants will be randomized (2 treatment, 1 control/placebo) and receive monthly infusion for 6 months. The treatment phase is followed by additional outpatient visits at UCSF for observation and additional laboratory testing.

How long will this study last? The study participation is for 2 years.

Reimbursement: All volunteers will be reimbursed $100 for the screening visit, $100 for each mixed meal tolerance test and $25 for the visits which do not involve mixed meal tolerance test. In addition, parking will be reimbursed.

For more information please contact: clinicalresearch@diabetes.ucsf.edu or call Toll-Free at 844-T1D-UCSF (844-813-8273).

Learn more: www.extend-study.org