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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

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.