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| ID | Type | Description | Link |
|---|---|---|---|
| CAAE: 07943212.5.2002.0053 | Other Identifier | National Committee for Ethics in Research - CEP/CONEP BRAZIL |
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
| ANS Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diacerein | Active Comparator | 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 | Placebo Comparator | Placebo capsules once a day for the starting 28 days and two times daily for the remainder of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diacerein | Drug | Diacerein oral capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dra. Maria Cândida R. Parisi, PhD | Contact | +55 (019) 981962242 | emaildacandida@uol.com.br | |
| Aleksandra A. Silva, MSc | Contact | +55 (019) 99233-9701 | aleksandra.silva@anspharma.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Mario JA Saad, MD PhD | National Institute of Science and Technology of Obesity and Diabetes (CNPq) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Estudos em Diabetes e Hipertensão | Recruiting | Fortaleza | Ceará | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21610123 | Background | 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. | |
| 22275450 |
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| Placebo | Drug | Placebo oral capsules |
|
| Universidade Estadual de Feira de Santana | Recruiting | Feira de Santana | Estado de Bahia | Brazil |
|
| Universidade Estadual de Campinas | Recruiting | Campinas | São Paulo | Brazil |
|
| 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. |
| 21896669 | Background | 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. |
| 16389635 | Background | 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. |
| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| C025292 | diacerein |
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