Diacerein on Insulin Secretion in Diabetes

NCT01298882 | Completed Phase 2

• 1 other identifier: DIADM2-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Overweight; Obesity

Keywords

Type 2 diabetes mellitus; Overweight; Obesity

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Diacerein

EXPERIMENTAL

Drug: Diacerein

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Diacerein DRUG

Diacerein

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Unidad de Investigación Médica en Epidemiología Clínica

Guadalajara, Jalisco, 44380, Mexico

Location

Related Publications (1)

• Ramos-Zavala MG, Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Gonzalez-Lopez R, Santiago-Hernandez NJ. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care. 2011 Jul;34(7):1591-4. doi: 10.2337/dc11-0357. Epub 2011 May 24.

  PMID: 21610123 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Interventions

diacerein

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 18, 2011
• Last Updated: February 18, 2011

Record last verified: 2011-01

Locations

ME (1)