Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Diacerein in the Metabolic Control of Patients With Diabetes Mellitus Type 2 and Secondary Failure to Metformin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02177643
• Other study ID #: 07943212.5.2002.0053
• Secondary ID: CAAE: 07943212.5
• Status: Recruiting
• Phase: Phase 2
• First received: June 23, 2014
• Last updated: September 15, 2015
• Start date: January 2013

Study information

• Verified date: September 2015
• Source: University of Campinas, Brazil
• Contact: Dra. Maria Cândida R. Parisi, PhD
• Phone: +55 (019) 981962242
• Email: emaildacandida[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Considering that, Diacerein is on the market for almost 20 years, being used continuously in elderly patients with osteoarthritis without present significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes and in a previously study from Mexico. The aim of our study is to investigate the effect of Diacerein, a medication with anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.

Description:

This proof of concept study aims to access the metabolic control in patients with type 2 diabetes mellitus and secondary failure to metformin.

The Study is a Phase II, Multicenter, National, Prospective, Randomized, Double blind, Parallel Groups, Placebo Comparative Trial. UNICAMP (Hospital of Unicamp) is the coordinating center and we have the participation of the State University of Feira de Santana and the Center for Diabetes and Hypertension in Fortaleza.

Study Objectives: To investigate the effect of Diacerein administered for 12 weeks; glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment. The Total Number of patients will be approximately 60, 30 patients in each group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diabetes mellitus (DM) type 2 between 6 months to 10 years of disease

• Body mass index between 25 and 35 kg/m2

• Fasting glucose between 120 and 250 mg/dL

• Glycated Hb A1c greater than 7,5 %

• Taking Metformin (dose above 1700 mg/day) with or without other secretagogue.

Exclusion Criteria:

• Subjects with DM1

• Subjects with DM2 using insulin

• Subjects with DM2 with chronic complications that already have clinical consequences

• Subjects with other types of diabetes

• Creatinine serum greater than 1.4 mg/dl (female) and 1.5 mg/dl (male)

• History of heart disease and/or severe concomitant diseases such as liver, coronary artery, renal

• History of severe psychiatric or neurological disorders

• History of alcohol abuse and/or illegal drugs or psychotropic medicines in the past six months

• Hypersensitivity to any component of the of study drug and placebo formulation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes-Related Complications
• Insulin Resistance

Intervention

Drug:
• Diacerein
Diacerein oral capsules
• Placebo
Placebo oral capsules

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Campinas	Campinas	São Paulo
Brazil	Universidade Estadual de Feira de Santana	Feira de Santana	Bahia
Brazil	Centro de Estudos em Diabetes e Hipertensão	Fortaleza	Ceará

Sponsors (3)

Lead Sponsor	Collaborator
University of Campinas, Brazil	ANS Pharma, Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Ramos-Zavala MG, González-Ortiz M, Martínez-Abundis E, Robles-Cervantes JA, González-López R, Santiago-Hernández 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. — View Citation

Tobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Prada PO, Saad MJ. Comment on: Ramos-Zavala et al. Effect of diacerein on insulin secretion and metabolic control in drug-naïve patients with type 2 diabetes: a randomized clinical trial. Diabetes Care 2011;34:1591-1594. Diabetes Care. 2012 Feb;35(2):e13; author reply e14. doi: 10.2337/dc11-1856. — View Citation

Tobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araújo TG, Santos-Silva JC, Zollner RL, Boechat LH, Carvalheira JB, Prada PO, Saad MJ. Diacerhein improves glucose tolerance and insulin sensitivity in mice on a high-fat diet. Endocrinology. 2011 Nov;152(11):4080-93. doi: 10.1210/en.2011-0249. Epub 2011 Sep 6. — View Citation

Velloso LA, Folli F, Perego L, Saad MJ. The multi-faceted cross-talk between the insulin and angiotensin II signaling systems. Diabetes Metab Res Rev. 2006 Mar-Apr;22(2):98-107. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Glucose Concentration		Baseline, 12 weeks	No
Primary	Fasting Insulin Concentration		Baseline, 12 weeks	No
Primary	HbA1c - glycated haemoglobin		Baseline, 12 weeks	No
Primary	Inflammatory Activity Profile	TNFa IL6 IL1ß C-Reactive Protein (CRP)	Baseline, 12 weeks	No
Primary	Lipid Panel		Baseline, 12 weeks	No
Primary	Hepatic Function Panel		Baseline, 12 weeks	No

External Links

•   Diacerhein Improves Glucose Tolerance and Insulin Sensitivity in Mice on a High-Fat Diet