Efficacy and safety of diacerein in patients with inadequately controlled type 2 diabetes: A randomized controlled trial

Abstract

OBJECTIVE To assess, in a randomized, double-blind, and placebo-controlled trial, the efficacy and safety of diacerein, an immunemodulator anti-inflammatory drug, in improving glycemic control of patients with type 2 diabetes. RESEARCH DESIGN AND METHODS Eighty-four patients with HbA1c between 7.5 and 9.5% (58-80 mmol/mol) were randomized to 48-week treatment with placebo (n = 41) or diacerein 100 mg/day (n = 43). The primary outcome was the difference in mean HbA1c changes during treatment. Secondary outcomes were other efficacy and safety measurements. A general linear regression with repeated measures, adjusted for age, sex, diabetes duration, and each baseline value, was used to estimate differences in mean changes. Both intention-to-treat (ITT) analysis and per-protocol analysis (excluding 10 patients who interrupted treatment) were performed.