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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208309
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Collaborators:
University of Campinas, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Complications of Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Drug: Diacerein Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Diacerein in the Metabolic Control of Patients With Diabetes Mellitus Type 2 and Secondary Failure to Metformin
Study Start Date : January 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 remainder of the study.
Drug: Diacerein
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



Primary Outcome Measures :
  1. Fasting Glucose [ Time Frame: 4 weeks ]
  2. HbA1c - glycated haemoglobin [ Time Frame: 12 weeks ]
  3. Cholesterol [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208309


Locations
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Brazil
Universidade Estadual de Feira de Santana
Feira de Santana, Bahia, Brazil
Centro de Estudos em Diabetes e Hipertensão
Fortaleza, Ceará, Brazil
Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
Sponsors and Collaborators
ANS Pharma
University of Campinas, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Additional Information:
Publications:
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Responsible Party: ANS Pharma
ClinicalTrials.gov Identifier: NCT03208309    
Other Study ID Numbers: 072/2011
Parecer CEP072/2011 ( Other Identifier: CEP FCM UNICAMP )
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diacetylrhein
Anti-Inflammatory Agents