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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANS Pharma
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; University of Campinas, Brazil
• Treatments: Diacetylrhein; Metformin

Criteria

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.