NCT02293837

Tocilizumab (TCZ) in New-onset Type 1 Diabetes

Preserving Beta-Cell Function With Tocilizumab in New-onset Type 1 Diabetes (ITN058AI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Staggered enrollment is planned for this trial. Prior to initiating the study in the pediatric age group (6-17 years old), 30-99 eligible adults (ages 18-45 years) will be randomized 2:1 to tocilizumab or placebo, respectively. Once the first thirty adult participants have completed 12 weeks of treatment, the FDA and Data and Safety Monitoring Board (DSMB) will review available data (e.g., interim analysis) to weigh potential risks and benefits before opening the trial to pediatric participants. As of ≥ May 15, 2017: Study enrollment limited to participants ages 6 to 17 years inclusive.

Conditions

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

Interventions

Type	Name	Description
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 \[Standard of Care, SOC\])

Timeline

• Start date: 2015-03-12
• Primary completion: 2019-07-10
• Completion: 2020-08-31
• First posted: 2014-11-18
• Last updated: 2021-09-08
• Results posted: 2021-08-17

Locations

19 sites across 2 countries: United States, Australia