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Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes

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ClinicalTrials.gov Identifier: NCT01326533
Recruitment Status : Completed
First Posted : March 31, 2011
Results First Posted : January 29, 2016
Last Update Posted : February 26, 2016
Information provided by (Responsible Party):

March 29, 2011
March 31, 2011
December 22, 2015
January 29, 2016
February 26, 2016
March 2011
March 2013   (Final data collection date for primary outcome measure)
Insulin Sensitivity [ Time Frame: 13 weeks after baseline measurement ]
Change from baseline in the insulin sensitivity index (Si)
Insulin Sensitivity [ Time Frame: Frequently sampled intravenous glucose tolerance testing (FSIGTT) at baseline and 3 months ]
Glucose metabolism, regulated by insulin secretion and sensitivity, as measured by FSIGTT, will improve in subjects with pre-diabetes treated with hydroxychloroquine compared with placebo for approximately 13 weeks.
Complete list of historical versions of study NCT01326533 on ClinicalTrials.gov Archive Site
Beta Cell Function [ Time Frame: 13 weeks after baseline measurement ]
Change from baseline in the disposition index (DI)
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Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes
Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes
The purpose of this study is to determine the short-term effects of the antimalarial medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.
Diabetes is approaching epidemic proportions in the United States. This study evaluates the mechanisms of action of a generic drug that may have effects on glucose metabolism.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Drug: hydroxychloroquine
    Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules
    Other Name: Plaquenil
  • Other: Placebo
    Thirteen weeks of oral placebo provided as capsules
    Other Name: microcellulose placebo
  • Experimental: hydroxychloroquine
    Thirteen weeks of daily hydroxychloroquine following FSIGTT testing
    Intervention: Drug: hydroxychloroquine
  • Placebo Comparator: Placebo
    Thirteen weeks of daily placebo following FSIGTT testing
    Intervention: Other: Placebo
Wasko MC, McClure CK, Kelsey SF, Huber K, Orchard T, Toledo FG. Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial. Diabetologia. 2015 Oct;58(10):2336-43. doi: 10.1007/s00125-015-3689-2. Epub 2015 Jul 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2014
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age > or = 18, able to provide informed consent
  2. Body-mass index greater than or equal to 25
  3. Presence of at least one indicator of insulin resistance from the following list:

    • Family history of Type 2 diabetes (parent, sibling)
    • Fasting glucose 100 - 125 mg/dl
    • Fasting serum insulin greater than or equal to 7uU/ml
    • Personal history of gestational diabetes
  4. Negative pregnancy test for women with childbearing potential

Exclusion Criteria:

  1. Diagnosis of diabetes mellitus Type 1 or Type 2
  2. Active autoimmune disease, chronic infection, current malignancy (excluding basal cell carcinoma), or other active inflammatory state that, in the opinion of the investigators, would affect insulin sensitivity
  3. Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months
  4. Known allergy or intolerance to HCQ
  5. Known glucose-6 phosphate dehydrogenase deficiency
  6. Known eye disease associated with retinal pigmentation abnormalities
  7. Known diabetic retinopathy requiring past or planned laser therapy
  8. Inability to comply with visit schedule and protocol requirements
  9. Inability to manage and take medication as instructed
  10. Current or planned pregnancy in upcoming 12 months
  11. Inability or unwillingness to use reliable method of contraception (for women of childbearing years, men, or men's partners with childbearing potential), such as oral contraceptive pills, barrier method (diaphragm and condom with spermicide), intrauterine device, or depo-provera injections for 3 months prior to enrollment
  12. Anemia (HGB < 9)
  13. Any history of bariatric (weight loss) surgery
  14. Current use of the medication Glucophage (metformin)
  15. Weight changes of 6 pounds or more in the past 4 weeks
  16. Any other underlying or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
5R21DK082878-02 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Frederico Toledo, University of Pittsburgh
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Frederico Toledo, MD University of Pittsburgh
University of Pittsburgh
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP