Diacerein on Insulin Secretion in Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus; Overweight; Obesity
• Interventions: Other: Placebo; Drug: Diacerein

• Registration Number: NCT01298882
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-02-16
• Last Update Submitted: 2011-02-16
• Study First Posted: 2011-02-18
• Last Update Posted: 2011-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Diacerein	Diacerein	-

Primary Outcome Measures

Name	Time	Method
Fasting insulin concentration	2 mo
Fasting glucose concentration	2 mo
A1C concentration	2 mo
First phase of insulin secretion	2 mo
Late phase of insulin secretion	2 mo
Total insulin secretion concentration	2 mo

Trial Locations

Locations (1)

Unidad de Investigación Médica en Epidemiología Clínica; 🇲🇽 Guadalajara, Jalisco, Mexico