Diacerein, a IL1-β inhibitor, is approved in some countries for osteoarthritis. This randomized controlled trial evaluated diacerein in adults with type 2 diabetes. A group of 84 participants receiving either diacerein or placebo were followed for 48 weeks.
The IL1-β inhibitor reduced A1c significantly by 0.6% and 0.35% at 24 and 48 weeks. Although 65% of treatment group experienced some degree of diarrhea, no major adverse events were noted.
Diacerein could be a reasonable anti-diabetic agent particularly in those with osteoarthritis. More importantly, the study gives clues to another pathogenesis route of diabetes; namely inflammation.
I anticipate that anti-inflammatory targets would be critical to the future of diabetes research.
Randomized Cont Trial
Objective: To assess, in a randomized, double-blind, and placebo-controlled trial, the efficacy and safety of DIACEREIN, an immune modulator anti-inflammatory drug, in improving glycemic control of patients with type 2 diabetes.
Research Design and Methods: 84 patients with HbA1c 7.5-9.5% 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.
Diacerein reduced HbA1c compared with placebo by 0.35% in the ITT analysis and by 0.41% (P = 0.023) in the per-protocol analysis.
The peak of effect occurred at 24th week of treatment −0.61%, [P = 0.014] and −0.78% [P = 0.005], respectively), but it attenuated toward nonsignificant differences at 48th week.
No significant effect of diacerein was observed in other efficacy and safety measures. Diarrhea occurred in 65% of patients receiving diacerein and caused treatment interruption in 16%. Seven patients in the diacerein group reduced insulin dosage, whereas 10 in the placebo group increased it.
Mild hypoglycemic events were equally observed.
Diacerein reduced mean HbA1c levels, with peak of effect at the 24th week of treatment. The drug was well tolerated and may be indicated as adjunct treatment in patients with type 2 diabetes, particularly in those with osteoarthritis.