Clinical trial NCT02177643: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes-Related Complications
Diabetes Mellitus, Type 2
Insulin Resistance
Keywords: Diabetes
Diacerein
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: ANS Pharma
First posted: 2014-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fasting Glucose Concentration
timeFrame: Baseline, 12 weeks
measure: Fasting Insulin Concentration
timeFrame: Baseline, 12 weeks
measure: HbA1c - glycated haemoglobin
timeFrame: Baseline, 12 weeks
measure: Inflammatory Activity Profile
timeFrame: Baseline, 12 weeks
measure: Lipid Panel
timeFrame: Baseline, 12 weeks
measure: Hepatic Function Panel
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Feira de Santana
country: Brazil
facility: Universidade Estadual de Feira de Santana
state: Bahia
city: Fortaleza
country: Brazil
facility: Centro de Estudos em Diabetes e Hipertensão
state: Ceará
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas
state: São Paulo
Study officials:
affiliation: National Institute of Science and Technology of Obesity and Diabetes (CNPq)
name: Dr. Mario JA Saad, MD PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.