Diacerein on Insulin Secretion in Diabetes

Obesity Clinical Trial

Official title:

Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298882
• Other study ID #: DIADM2-001
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2011
• Last updated: February 16, 2011

Study information

• Verified date: January 2011
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en Salud
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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.

Study Design

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Diacerein

Other:
• Placebo

Locations

Country	Name	City	State
Mexico	Unidad de Investigación Médica en Epidemiología Clínica	Guadalajara	Jalisco

Sponsors (2)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting insulin concentration		2 mo	No
Primary	Fasting glucose concentration		2 mo	No
Primary	A1C concentration		2 mo	No
Primary	First phase of insulin secretion		2 mo	No
Primary	Late phase of insulin secretion		2 mo	No
Primary	Total insulin secretion concentration		2 mo	No