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

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Diacerein

Placebo

About this trial

This is an interventional treatment trial for Diabetes-Related Complications focused on measuring Diabetes, Diacerein

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Universidade Estadual de Feira de SantanaRecruiting
Centro de Estudos em Diabetes e HipertensãoRecruiting
Universidade Estadual de CampinasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Diacerein

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Fasting Glucose Concentration

Fasting Insulin Concentration

HbA1c - glycated haemoglobin

Inflammatory Activity Profile

TNFα IL6 IL1β C-Reactive Protein (CRP)

Lipid Panel

Hepatic Function Panel

Secondary Outcome Measures

Full Information

NCT ID

NCT02177643

First Posted

June 23, 2014

Last Updated

September 15, 2015

Sponsor

University of Campinas, Brazil

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico, ANS Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02177643

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Campinas, Brazil

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico, ANS Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Diabetes, Diacerein

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diacerein

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Diacerein

Other Intervention Name(s)

Artrodar - TRB Pharma

Intervention Description

Diacerein oral capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo oral capsules

Primary Outcome Measure Information:

Title

Fasting Glucose Concentration

Time Frame

Baseline, 12 weeks

Title

Fasting Insulin Concentration

Time Frame

Baseline, 12 weeks

Title

HbA1c - glycated haemoglobin

Time Frame

Baseline, 12 weeks

Title

Inflammatory Activity Profile

Description

TNFα IL6 IL1β C-Reactive Protein (CRP)

Time Frame

Baseline, 12 weeks

Title

Lipid Panel

Time Frame

Baseline, 12 weeks

Title

Hepatic Function Panel

Time Frame

Baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dra. Maria Cândida R. Parisi, PhD

Phone

+55 (019) 981962242

emaildacandida@uol.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Aleksandra A. Silva, MSc

Phone

+55 (019) 99233-9701

aleksandra.silva@anspharma.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Mario JA Saad, MD PhD

Organizational Affiliation

National Institute of Science and Technology of Obesity and Diabetes (CNPq)

Official's Role

Study Director

Facility Information:

Facility Name

Universidade Estadual de Feira de Santana

City

Feira de Santana

State/Province

Bahia

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dra. Ana Mayra A. Oliveira, PhD

Phone

+55 (075) 3625-4027

anamayra@uol.com.br

First Name & Middle Initial & Last Name & Degree

Dra. Ana Mayra A. Oliveira, PhD

Facility Name

Centro de Estudos em Diabetes e Hipertensão

City

Fortaleza

State/Province

Ceará

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dra. Adriana C. Forti, PhD

Phone

+55 (085) 3105-8300

cedh@cedh.med.br

First Name & Middle Initial & Last Name & Degree

Dra. Adriana C. Forti, PhD

Facility Name

Universidade Estadual de Campinas

City

Campinas

State/Province

São Paulo

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dra. Maria Cândida R. Parisi, PhD

Phone

+55 (019) 98196-2242

emaildacandida@uol.com.br

First Name & Middle Initial & Last Name & Degree

Dr. Daniel Minuti, MD Msc

Phone

+55 (019) 98128-2535

danielminutti@yahoo.com.br

First Name & Middle Initial & Last Name & Degree

Dr. Daniel Minuti, MD Msc

12. IPD Sharing Statement

Citations:

PubMed Identifier

21610123

Citation

Ramos-Zavala MG, Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Gonzalez-Lopez R, Santiago-Hernandez NJ. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care. 2011 Jul;34(7):1591-4. doi: 10.2337/dc11-0357. Epub 2011 May 24.

Results Reference

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PubMed Identifier

22275450

Citation

Tobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Prada PO, Saad MJ. Comment on: Ramos-Zavala et al. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care 2011;34:1591-1594. Diabetes Care. 2012 Feb;35(2):e13; author reply e14. doi: 10.2337/dc11-1856. No abstract available.

Results Reference

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PubMed Identifier

21896669

Citation

Tobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Santos-Silva JC, Zollner RL, Boechat LH, Carvalheira JB, Prada PO, Saad MJ. Diacerhein improves glucose tolerance and insulin sensitivity in mice on a high-fat diet. Endocrinology. 2011 Nov;152(11):4080-93. doi: 10.1210/en.2011-0249. Epub 2011 Sep 6.

Results Reference

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PubMed Identifier

16389635

Citation

Velloso LA, Folli F, Perego L, Saad MJ. The multi-faceted cross-talk between the insulin and angiotensin II signaling systems. Diabetes Metab Res Rev. 2006 Mar-Apr;22(2):98-107. doi: 10.1002/dmrr.611.

Results Reference

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

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