Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

(TN-22 Trial)

Recruiting in Palo Alto (17 mi)

+50 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D.

Research Team

Carla Greenbaum, MD

Principal Investigator

Type 1 Diabetes TrialNet

Eligibility Criteria

Inclusion Criteria

This means that the person must be 3 years or older at the time that they are randomly chosen to participate in the study.

but unable to communicate This person is willing to provide consent but is unable to communicate verbally.

thereafter, is found to be pregnant, she will be discontinued from the study and the study medication will be withheld from her

Treatment Details

Interventions

• Hydroxychloroquine (Antimalarial)
• Placebo (Drug)

Participant Groups

Group I: Hydroxychloroquine Experimental Treatment 1 Intervention

Hydroxychloroquine compound for oral use

Group II: Placebo Placebo Group 1 Intervention

Placebo tablet matching active drug

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Dr. Aaron J. Kowalski

Juvenile Diabetes Research Foundation

Chief Executive Officer since 2019

PhD in Microbiology and Molecular Genetics from Rutgers University

Dr. Thomas Danne

Juvenile Diabetes Research Foundation

Chief Medical Officer

MD from Albert Einstein College of Medicine