Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin
Condition: Complications of Diabetes Mellitus; Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Diacerein; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Diacerein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment