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