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: Completed

Administrative data

• NCT number: NCT03208309
• Other study ID #: 072/2011
• Secondary ID: Parecer CEP072/2
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2017
• Last updated: July 3, 2017
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2017
• Source: ANS Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Considering that, Diacerein is on the market for 16 years being used continuously in elderly patients with osteoarthritis without experience significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes treated with this medicine.

The aim of this 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 coordinator center and the investigators and research center participating are from the State University of Feira de Santana (BA) and the Center for Diabetes and Hypertension in Fortaleza (CE).

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

Diagnostic Criteria - Diabetes mellitus 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 % and taking metformin (dose above 1700 mg / day) with or without other secretagogue.

Inclusion Criteria - male or female (not pregnant) , aged between 35 and 65 years who present clinical symptoms of type 2 diabetes between 6 months to 10 years of disease, according to the diagnostic criteria.

Exclusion Criteria - Patients with DM1, DM2 using insulin and other types of diabetes.

T2DM with chronic complications that already have clinical consequences, serum creatinine greater than 1.5 mg/dl, history of heart disease and severe concomitant diseases such as liver, coronary artery, renal, with severe psychiatric or neurological disorders .

Patients with a history of abuse of alcohol and / or illegal drugs or psychotropic medicines in the past six months, hypersensitivity to any of the components of the of study drug formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diabetes mellitus 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 % and taking metformin (dose above 1700 mg / day) with or without other secretagogue

• Male or female (not pregnant), who present clinical symptoms of type 2 diabetes between 6 months to 10 years of disease, according to the diagnostic criteria.

Exclusion Criteria:

• Patients with DM1, DM2 using insulin and other types of diabetes

• T2DM with chronic complications that already have clinical consequences

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

• History of heart disease and severe concomitant diseases such as liver, coronary artery, renal, with severe psychiatric or neurological disorders

• Patients with a history of abuse of alcohol and/or illegal drugs or psychotropic medicines in the past six months

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

Related Conditions & MeSH terms

• Complications of Diabetes Mellitus
• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Diacerein

• Placebo

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

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		4 weeks
Primary	HbA1c - glycated haemoglobin		12 weeks
Primary	Cholesterol		12 weeks

External Links

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