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

September 15, 2015 updated by: Aleksandra Alves Silva, University of Campinas, Brazil

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Bahia
      • Feira de Santana, Bahia, Brazil
        • Recruiting
        • Universidade Estadual de Feira de Santana
        • Contact:
        • Principal Investigator:
          • Dra. Ana Mayra A. Oliveira, PhD
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Recruiting
        • Centro de Estudos em Diabetes e Hipertensão
        • Contact:
          • Dra. Adriana C. Forti, PhD
          • Phone Number: +55 (085) 3105-8300
          • Email: cedh@cedh.med.br
        • Principal Investigator:
          • Dra. Adriana C. Forti, PhD
    • São Paulo
      • Campinas, São Paulo, Brazil
        • Recruiting
        • Universidade Estadual de Campinas
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dr. Daniel Minuti, MD Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsules once a day for the starting 28 days and two times daily for the remainder of the study.
Drug: Placebo
Placebo oral capsules
Active Comparator: 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 remains of the study.
Drug: Diacerein
Diacerein oral capsules
Other Names:
  • Artrodar - TRB Pharma

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
ANS Pharma

Investigators

  • Study Director: Dr. Mario JA Saad, MD PhD, National Institute of Science and Technology of Obesity and Diabetes (CNPq)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07943212.5.2002.0053
  • CAAE: 07943212.5.2002.0053 (Other Identifier: National Committee for Ethics in Research - CEP/CONEP BRAZIL)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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