CHLOROQUINE FOR PREVENTION OF ABNORMAL GLUCOSE TOLERANCE AND DIABETES IN INDIVIDUALS AT-RISK FOR TYPE 1 DIABETES MELLITUS

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 201

Inclusion Criteria

1. A participant in TrialNet Pathway to Prevention Study (TN01).

2. Age = 3 years at the time of randomization in this trial.

3. Willing to provide informed consent or, if the participant is <18 years of age, have a parent or legal guardian provide informed consent.

4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) prior to baseline (Visit 0). If previous abnormal glucose tolerance, has had two consecutive OGTTs with normal glucose tolerance:
a. Fasting plasma glucose < 110 mg/dL (6.1 mmol/L), and
b. 2 hour plasma glucose <140 mg/dL (7.8 mmol/L), and
c. 30, 60, or 90 minute value on OGTT< 200mg/dL (11.1 mmol/L).

5. Two or more diabetes-related autoantibodies present on two separate samples, one of which was drawn within the past six months (210 days). Confirmation does not have to involve the same 2 autoantibodies.

6. Weight = 12 kg at the time of 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 84
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Abnormal Glucose Tolerance or Diabetes
a. Fasting plasma glucose = 110 mg/dL (6.1 mmol/L), or
b. 2 hour plasma glucose = 140 mg/dL (7.8 mmol/L), or
c. 30, 60, 90 minute plasma glucose during OGTT = 200 mg/dL (11.1 mmol/L)

2. History of treatment with insulin or other diabetes therapies.

3. Ongoing use of medications known to influence glucose tolerance, e.g. glucocorticoids, growth hormone, anticonvulsants, thiazide or potassium-depleting diuretics, beta adrenergic blockers, niacin and antipsychotics. Participants on such medications should be changed to a suitable alternative, if available, by their primary care provider, and will become eligible one month after medication is discontinued.

4. Ongoing or anticipated future use of any medications known to impact T1D progression or have untoward interactions with hydroxychloroquine.

5. Known hypersensitivity to 4-aminoquinoline compounds.

6. G6PD deficiency.

7. History of retinopathy.

8. Active infection at time of randomization.

9. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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