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

Phase 2

Completed

• Conditions: Complications of Diabetes Mellitus; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Diacerein

• Registration Number: NCT03208309
• Lead Sponsor: ANS Pharma

Brief 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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Study First Submitted: 2017-06-27
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-03
• Last Update Submitted: 2017-07-03
• Study First Posted: 2017-07-05
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion 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
• Male or female (not pregnant), who present clinical symptoms of type 2 diabetes between 6 months to 10 years of disease, according to the diagnostic criteria.

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Exclusion Criteria

• Patients with DM1, DM2 using insulin and other types of diabetes
• T2DM with chronic complications that already have clinical consequences
• Creatinine serum greater than 1.4 (female) and 1.5 mg/dl (male)
• 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 component of the of study drug and placebo formulation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsules once a day for the starting 28 days and two times daily for the remainder of the study.
Diacerein	Diacerein	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 remainder of the study.

Primary Outcome Measures

Name	Time	Method
Fasting Glucose	4 weeks
HbA1c - glycated haemoglobin	12 weeks
Cholesterol	12 weeks

Trial Locations

Locations (3)

Universidade Estadual de Feira de Santana; 🇧🇷 Feira de Santana, Bahia, Brazil

Universidade Estadual de Campinas; 🇧🇷 Campinas, São Paulo, Brazil

Centro de Estudos em Diabetes e Hipertensão; 🇧🇷 Fortaleza, Ceará, Brazil