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 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.
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.
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