Diacerein on Insulin Secretion in Diabetes

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 2

Conditions: Overweight; Type 2 Diabetes Mellitus; Obesity

Treatments: Drug: Diacerein; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01298882

DIADM2-001

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fasting glucose levels between 7.0 and 11.1 mmol/L
• A1C levels between 7 and 9%
• Same residential area and socioeconomic status
• Excessively sedentary or participated in heavy physical activity
• Nonsmokers
• Body weight was stable for at least 3 months before the study
• Blood pressure was <130/80 mm Hg

Exclusion criteria

• Personal history of hepatic, renal or coronary artery disease
• Medications known to affect metabolism during the previous 6 months.

Trial design

0 participants in 2 patient groups, including a placebo group

Diacerein

Experimental group

Treatment:

Drug: Diacerein

Placebo

Placebo Comparator group

Treatment:

Other: Placebo