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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Diacerein in the Metabolic Control of Patients With Diabetes Mellitus Type 2 and Secondary Failure to Metformin

Conditions
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Diabetes-Related Complications, Diabetes Mellitus, Type 2, Insulin Resistance

Intervention / Treatment
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* Drug: Diacerein
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diacerein<br>Diacerein 50 mg immediate release capsule, once daily for the starting 28 days and Diacerein 50 mg immediate release capsule twice a day for the remains of the study. | Drug: Diacerein<br>* Diacerein oral capsules<br>* Other names: Artrodar - TRB Pharma;|
| Placebo Comparator: Placebo<br>Placebo capsules once a day for the starting 28 days and two times daily for the remainder of the study. | Drug: Placebo<br>* Placebo oral capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose Concentration |  | Baseline, 12 weeks | 
| Fasting Insulin Concentration |  | Baseline, 12 weeks | 
| HbA1c - glycated haemoglobin |  | Baseline, 12 weeks | 
| Inflammatory Activity Profile | TNFα IL6 IL1β C-Reactive Protein (CRP) | Baseline, 12 weeks | 
| Lipid Panel |  | Baseline, 12 weeks | 
| Hepatic Function Panel |  | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Diacerein