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

Primary Purpose

Complications of Diabetes Mellitus, Diabetes Mellitus, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Diacerein
Placebo
Sponsored by
ANS Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications of Diabetes Mellitus

Eligibility Criteria

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

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.

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.

Sites / Locations

  • Universidade Estadual de Feira de Santana
  • Centro de Estudos em Diabetes e Hipertensão
  • Universidade Estadual de Campinas

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 remainder 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
HbA1c - glycated haemoglobin
Cholesterol

Secondary Outcome Measures

Full Information

First Posted
June 27, 2017
Last Updated
July 3, 2017
Sponsor
ANS Pharma
Collaborators
University of Campinas, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT03208309
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
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANS Pharma
Collaborators
University of Campinas, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications of Diabetes Mellitus, Diabetes Mellitus, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

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 remainder 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
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Fasting Glucose
Time Frame
4 weeks
Title
HbA1c - glycated haemoglobin
Time Frame
12 weeks
Title
Cholesterol
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Facility Information:
Facility Name
Universidade Estadual de Feira de Santana
City
Feira de Santana
State/Province
Bahia
Country
Brazil
Facility Name
Centro de Estudos em Diabetes e Hipertensão
City
Fortaleza
State/Province
Ceará
Country
Brazil
Facility Name
Universidade Estadual de Campinas
City
Campinas
State/Province
São Paulo
Country
Brazil

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

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