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Abstract

Global Journal of Endocrinological Metabolism

A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of Hydroxychloroquine in Patients with Type 2 Diabetes Mellitus

Submission: July 30, 2018; Published: August 14, 2018

DOI: 10.31031/GJEM.2018.02.000543

ISSN 2637-8019
Volume2 Issue3

Abstract

Objective: Observational study indicate that Hydroxychloroquine (HCQ) 400mg helps to achieve target glycemic parameter as add on in inadequately control type 2 diabetes patients (T2DM). We examine the effect of Hydroxychloroquine on reduction in glycemic parameters in uncontrolled T2DM patients.

Methods: A 6month randomized, double-blind, placebo controlled trial of hydroxychloroquine and placebo in 39subjects (22m/17f) of ages 40-70years (y), with HbA1c >8%, Weight >60kg, and T1D >12 months was conducted at a university outpatient facility. The hydroxychloroquine group consisted of 20 subjects (12m/8f), of age 55.0±2.5 y; while the control group was made up of 19 subjects (10m/9f), of age 54.5±3.1y. Patients were randomized to double-blind hydroxychloroquine 400mg OD or placebo added on to metformin 1500mg and Glimepiride 4mg following a 4 week. The primary end point was the change from baseline to week 12 in HbA1c. Key secondary end points included change from baseline to week 24 in fasting plasma glucose (FPG), post prandial plasma glucose (PPG), change in weight and the proportion of patients achieving HbA1c target (<7%).

Result: There was a significantly greater reduction in HbA1c at 24 weeks with HCQ add-on (-1.3±0.5% [p=0.001]) versus placebo (-0.6±0.01%[p=0.031]). There was statistically significant reductions in fasting plasma glucose and 2-h postprandial glucose with HCQ group as compared to placebo group. A larger proportion of patients achieved HbA1c <7% with HCQ add-on (60%) versus placebo add-on (21%). Adverse events were similar between treatment groups. Episodes of hypoglycaemia were infrequent in both treatment arms, and there were no episodes of major hypoglycaemia. There were statistically reductions in mean body weight (LOCF) in HCQ group. Mean change in body weight (95% CI) at week 24 was 6.12±1.1kg for the HCQ group and increased +0.9±0.4 kg for the placebo group.

Conclusion: Patients with inadequately controlled type 2 diabetes mellitus, HCQ 400mg provided clinically meaningful improvements in glycemic control without weight gain or increased risk of hypoglycaemia.

Keywords: Hydroxychloroquine; Type 2 diabetes mellitus; HbA1c

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