Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα)
inhibition with diacerein administration on insulin secretion and metabolic control of
drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.
Hypothesis. Diacerein administration improves insulin secretion and metabolic control of
drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.
Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial.
Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A
metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well
as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion
and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15
days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed
rank and Mann-Whitney U test.
Phase:
Phase 2
Details
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Collaborator:
National Council of Science and Technology, Mexico