Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin
NCT ID: NCT02177643
Last Updated: 2015-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin
NCT03208309
Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
NCT02242149
Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus
NCT03606694
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
NCT01640873
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
NCT00857558
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Diacerein
Diacerein oral capsules
Placebo
Placebo capsules once a day for the starting 28 days and two times daily for the remainder of the study.
Placebo
Placebo oral capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Diacerein
Diacerein oral capsules
Placebo
Placebo oral capsules
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
ANS Pharma
INDUSTRY
University of Campinas, Brazil
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aleksandra Alves Silva
Study Director - Dr. Mario José Abdalla Saad - National Institute of Science and Technology of Obesity and Diabetes
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr. Mario JA Saad, MD PhD
Role: STUDY_DIRECTOR
National Institute of Science and Technology of Obesity and Diabetes (CNPq)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAAE: 07943212.5.2002.0053
Identifier Type: OTHER
Identifier Source: secondary_id
07943212.5.2002.0053
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.