Clinical Trial Details

Overview

Research Study Summary

Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes (the EXTEND Study)

Purpose

The healthy insulin-producing beta cells that you have left when you are first diagnosed with type 1 diabetes are precious. The aim of the EXTEND Study is to test whether a therapy called tocilizumab (Actemra®) can stop the immune system from attacking these remaining beta cells and possibly extend the ability to naturally produce insulin. Currently there are no approved treatments that are able to do this.

Participants in the EXTEND study will be randomly assigned to one of two groups. One group will be given the study drug, tocilizumab, and the other group will receive an inactive substance made to look like the study drug, called a placebo.

Tocilizumab or placebo will be given once every 4 weeks over a 24 week period. There will be a total of 7 intravenous infusions with four additional follow-up visits during the next 18 months. Total study time is 2 years.

To Learn more

CW ID: 209920
Date Last Changed: August 21, 2015

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
18 to 45 Years
Overall Status
Recruiting
Lead Sponsor
NIAID
Duration
2 Years
Facility Type
Out-Patient

Eligibility

You may be eligible to participate in the EXTEND Study if you:

  • Are male or female, aged 18-45
  • Have been diagnosed with type 1 diabetes within the last 3 months
  • Are in good general health

More Info

For more information, visit www.extend-study.org

Contact

Trudy Esrey
Stanford University
300 Pasteur Drive
Stanford, CA 94305
Phone: 650-498-4450

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