Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin
2 other identifiers
interventional
60
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedSeptember 17, 2015
September 1, 2015
3.6 years
June 23, 2014
September 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Fasting Glucose Concentration
Baseline, 12 weeks
Fasting Insulin Concentration
Baseline, 12 weeks
HbA1c - glycated haemoglobin
Baseline, 12 weeks
Inflammatory Activity Profile
TNFα IL6 IL1β C-Reactive Protein (CRP)
Baseline, 12 weeks
Lipid Panel
Baseline, 12 weeks
Hepatic Function Panel
Baseline, 12 weeks
Study Arms (2)
Diacerein
ACTIVE COMPARATORDiacerein 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
PLACEBO COMPARATORPlacebo capsules once a day for the starting 28 days and two times daily for the remainder of the study.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Campinas, Brazillead
- Conselho Nacional de Desenvolvimento Científico e Tecnológicocollaborator
- ANS Pharmacollaborator
Study Sites (3)
Centro de Estudos em Diabetes e Hipertensão
Fortaleza, Ceará, Brazil
Universidade Estadual de Feira de Santana
Feira de Santana, Estado de Bahia, Brazil
Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
Related Publications (4)
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.
PMID: 21610123BACKGROUNDTobar 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.
PMID: 22275450BACKGROUNDTobar 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.
PMID: 21896669BACKGROUNDVelloso 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.
PMID: 16389635BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Mario JA Saad, MD PhD
National Institute of Science and Technology of Obesity and Diabetes (CNPq)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Director - Dr. Mario José Abdalla Saad - National Institute of Science and Technology of Obesity and Diabetes
Study Record Dates
First Submitted
June 23, 2014
First Posted
June 27, 2014
Study Start
January 1, 2013
Primary Completion
August 1, 2016
Last Updated
September 17, 2015
Record last verified: 2015-09