Diacerein on Insulin Secretion in Diabetes
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.
|Type 2 Diabetes Mellitus Overweight Obesity||Drug: Diacerein Other: Placebo||Phase 2|
|Study Design:||Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity|
- Fasting insulin concentration [ Time Frame: 2 mo ]
- Fasting glucose concentration [ Time Frame: 2 mo ]
- A1C concentration [ Time Frame: 2 mo ]
- First phase of insulin secretion [ Time Frame: 2 mo ]
- Late phase of insulin secretion [ Time Frame: 2 mo ]
- Total insulin secretion concentration [ Time Frame: 2 mo ]
|Experimental: Diacerein||Drug: Diacerein|
|Placebo Comparator: Placebo||Other: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298882
|Unidad de Investigación Médica en Epidemiología Clínica|
|Guadalajara, Jalisco, Mexico, 44380|