Overview

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.