Effect of Diacerein in the Metabolic Control of Patients With Diabetes Mellitus Type 2 and Secondary Failure to Metformin
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Fasting Insulin Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Diacerein (Drug)
Placebo
Placebo capsules once a day for the starting 28 days and two times daily for the remainder of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Fasting Insulin Concentration
时间窗: Baseline, 12 weeks
Inflammatory Activity Profile
时间窗: Baseline, 12 weeks
TNFα IL6 IL1β C-Reactive Protein (CRP)
Fasting Glucose Concentration
时间窗: Baseline, 12 weeks
HbA1c - glycated haemoglobin
时间窗: Baseline, 12 weeks
Lipid Panel
时间窗: Baseline, 12 weeks
Hepatic Function Panel
时间窗: Baseline, 12 weeks
次要结局
未报告次要终点
研究者
Aleksandra Alves Silva
Study Director - Dr. Mario José Abdalla Saad - National Institute of Science and Technology of Obesity and Diabetes
University of Campinas, Brazil