Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus

Type1 Diabetes Mellitus Clinical Trial

— TN-22  

Official title:

Hydroxychloroquine for Prevention of Abnormal Glucose Tolerance and Diabetes in Individuals At-risk for Type 1 Diabetes Mellitus (T1D)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03428945
• Other study ID #: Hydroxychloroquine
• Secondary ID: UC4DK117009UC4DK
• Status: Terminated
• Phase: Phase 2
• Start date: August 15, 2018
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2023
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is testing a medication, called hydroxychloroquine (HCQ) to assess safety and effectiveness to prevent individuals at risk of type 1 diabetes (T1D) from progressing to type 1 diabetes.

HCQ is approved by the U.S. Food and Drug Administration as a treatment for malaria, lupus, and rheumatoid arthritis. HCQ has been used extensively for treatment of autoimmune disease in adults, children, and during pregnancy. This medication has not previously been studied as a treatment to prevent T1D.

The goal of this study is to learn if HCQ can help prevent or delay progression from normal glucose tolerance (Stage 1) to abnormal glucose tolerance (Stage 2) or type 1 diabetes (Stage 3).

The study involves 5 visits in the first 6 months, then 1 visit every 6 months for the remainder of the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 273
• Est. completion date: October 31, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

1. Participant in TrialNet Pathway to Prevention Study (TN01)

2. Age 3 years or greater at the time of randomization

3. Willing to provide informed consent

4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) of baseline

5. Two or more diabetes-related autoantibodies present on two separate samples

6. Weight of 12 kg or greater at screening

7. If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit

8. Anticipated ability to swallow study medication.

Exclusion Criteria:

1. Abnormal Glucose Tolerance or Diabetes

2. History of treatment with insulin or other diabetes therapies

3. Ongoing use of medications known to influence glucose tolerance

4. Ongoing or anticipated future use of medications known to have untoward interactions with hydroxychloroquine

5. Known hypersensitivity to 4-aminoquinoline compounds

6. G6PD deficiency

7. History of retinopathy

8. Have an active infection at time of randomization

9. Have serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection

10. Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.

11. Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.

12. Be pregnant or breastfeeding.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine for oral administration, dosed by weight
• Placebo
Placebo tablet identical to active drug

Locations

Country	Name	City	State
Australia	Women's and Children's Hospital, Adelaide	North Adelaide	South Australia
Australia	Walter and Eliza Hall Institute of Medical Research	Parkville	Victoria
Australia	Perth Children's Hospital	Perth	Western Australia
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Canada	IWK Health Center	Halifax
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Hospital For Sick Kids	Toronto	Ontario
Italy	San Raffaele Hospital	Milan
Sweden	Skane University Hospital	Malmö
United Kingdom	University of Bristol	Bristol	UK
United Kingdom	Royal Devon and Exeter Hospital	Exeter	Devon
United Kingdom	Harrogate and District NHS Foundation Trust	Harrogate	North Yorkshire
United Kingdom	Nottingham University Hospitals	Nottingham
United Kingdom	Plymouth Diabetes Clinical Research Unit	Plymouth	Devon
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Emory Children's Center	Atlanta	Georgia
United States	Barbara Davis Center	Aurora	Colorado
United States	St. Luke's Humphreys Diabetes Center	Boise	Idaho
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	UBMD Pediatrics	Buffalo	New York
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	Endocrinology Specialist / Greenville Health System	Greenville	South Carolina
United States	GHS - Pediatric Endocrinology	Greenville	South Carolina
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Indiana University - Riley Hospital for Children	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	Palm Research Center, Inc.	Las Vegas	Nevada
United States	University of Kentucky/UK Healthcare	Lexington	Kentucky
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of Louisville Pediatric Endocrinology	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt Eskind Diabetes Clinic	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	The University of Oklahoma	Oklahoma City	Oklahoma
United States	Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	University of California - San Francisco	San Francisco	California
United States	Benaroya Research Institute	Seattle	Washington
United States	Sanford Children's Specialty Clinic	Sioux Falls	South Dakota
United States	Stanford University	Stanford	California
United States	Joslin Center at SUNY Upstate Medical University	Syracuse	New York
United States	USF Diabetes Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Juvenile Diabetes Research Foundation

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Treatment Assignment Glucose Tolerance to Abnormal Glucose Tolerance or Diabetes	The primary outcome is the time in months from random treatment assignment to the development of confirmed abnormal glucose tolerance or clinical diabetes.	Glucose tolerance is measured every 6 months for up to 4 years

External Links

•   TrialNet Public Website