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

Phase 4 Completed 32 enrolled University of Pittsburgh National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupDouble-blindBasic science

Summary

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.

Timeline

Start: 2011-03
Primary completion: 2013-03
Completion: 2014-12

Outcome

Met primary endpoint

paper There was a positive change in insulin sensitivity with HCQ but not placebo (mean ± SEM: +20.0% ± 7.1% vs -18.4% ± 7.9%, respectively; p < 0.01; PMID 26197707 ↗

registry MEAN Hydroxychloroquine: 0.08 (Standard Error 0.03) 10^-4/pmol*l/min MEAN Placebo: -0.11 (Standard Error 0.04) 10^-4/pmol*l/min analysis (superiority or other test); Hydroxychloroquine vs Placebo; p <0.01; ANCOVA NCT01326533 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydroxychloroquine	Small molecule	400 mg	Oral