individuals at-risk for type 1 diabetes mellitus (T1D)
Conditions
Interventions
Trade Name: Hydroxychloroquine Sulfate 200mg tablet Sandoz, Inc. NDC # 0781-5994-01
Product Name: HYDROXYCHLOROQUINE SULPHATE
Product Code: P01BA02
Pharmaceutical Form: Capsule
Pharmaceutical form
Sponsors
TrialNet Coordinating Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Family history of Type 1 Diabetes or known positivity for one or more diabetes-related autoantibodies. 2. Age = 3 years at the time of randomization in this trial. 3. Willing to provide informed consent or, if the participant is =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. 11. Be Breastfeeding or pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, safety and mode of action of hydroxychloroquine to prevent progression from Stage 1 to Stage 2 or Stage 3 of T1D. The primary objective is to determine whether intervention with hydroxychloroquine will prevent or delay the progression from Stage 1 (normal glucose tolerance) to Stage 2 (abnormal glucose tolerance) or Stage 3 (clinically overt T1D).;Secondary Objective: Secondary outcomes include: the effect of hydroxychloroquine on the risk of T1D; analyses of metabolic and immune changes over time; safety and tolerability; evaluation of other possible factors on effect (association and effect modification); and mechanistic outcomes.Please enter information in English and add any other language that is applicable;Primary end point(s): The primary outcome is the elapsed time from random treatment assignment to the development of confirmed abnormal glucose tolerance or clinical diabetes among those enrolled in the primary analysis cohort consisting of participants with islet cell autoimmunity and absence of metabolic abnormalities (normal OGTT).The date of the confirmatory abnormal OGTT or diabetes will be considered as the date of reaching these study endpoints. It is expected that abnormal glucose tolerance will be detected prior to diabetes onset by OGTT; however, the presence of diabetes, without a previous abnormal OGTT, is also considered an endpoint.;Timepoint(s) of evaluation of this end point: The study endpoint will be evaluated for every 6 months via oral glucose tolerance tests. Participants who have progressed to Stage 2 T1D by virtue of having developed confirmed abnormal glucose tolerance will have reached the primary study endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): These participants who have developed abnormal glucose tolerance but have not progressed to Stage 3 T1D (clinical onset) will have the option to remain in this study without further therapy, undergoing close monitoring and safety assessments until the development of Stage 3 T1D (clinically overt diabetes) or until they enroll in another clinical trial, whichever comes first.Once participants reach Stage 3 (diagnosis of clinical diabetes), they will no longer be followed in the context of this protocol; however, they will be offered follow-up in the Long Term Investigative Follow- Up in TrialNet (LIFT) Study (TN16). Alternatively, individuals who progress to Stage 3 may be eligible for interventional studies sponsored by TrialNet or other organizations under separate INDs.;Timepoint(s) of evaluation of this end point: The study endpoint will be evaluated for every 6 months via oral glucose tolerance tests | — |
Countries
Australia, Canada, Finland, New Zealand, Sweden, United Kingdom, United States
Contacts
Public ContactColleen Maguire, MPH
TrialNet Coordinating Center
Outcome results
None listed