Tocilizumab (TCZ) in New-onset Type 1 Diabetes

Summary

Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.

Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.

Conditions

• Type 1 Diabetes Mellitus
• New-onset Type 1 Diabetes Mellitus
• T1DM
• T1D

Interventions

DRUG

Tocilizumab (TCZ)

Subjects assigned to this group will receive tocilizumab intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight \<30kg) every 4 weeks for 24 weeks.

DRUG

Placebo

Subjects assigned to this group will receive placebo intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight \<30kg) every 4 weeks for 24 weeks.

OTHER

Standard of Care

Participants will also receive standard intensive diabetes management (in accordance with the American Diabetes Association guidelines \[Standard of Care, SOC\])

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• PPD Development, LP

  collaborator INDUSTRY

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Carla Greenbaum · Benaroya Research Institute at Virginia Mason: Diabetes Research Program

• Jane Buckner, M.D. · Benaroya Research Institute at Virginia Mason: Diabetes Research Program

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-12

Primary Completion

2019-07-10

Completion

2020-08-31

Countries

• United States
• Australia

Study Locations