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
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- HbA1c - glycated haemoglobin
研究概览
简要总结
Considering that, Diacerein is on the market for 16 years being used continuously in elderly patients with osteoarthritis without experience significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes treated with this medicine.
The aim of this 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 coordinator center and the investigators and research center participating are from the State University of Feira de Santana (BA) and the Center for Diabetes and Hypertension in Fortaleza (CE).
Study Objectives: To investigate the effect of Diacerein administered for 12 weeks; glycemic and metabolic control; in patients with diabetes mellitus type 2 and secondary failure to metformin treatment. The Total Number of patients will be approximately 60, 30 patients in each group.
Diagnostic Criteria - Diabetes mellitus 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 % and taking metformin (dose above 1700 mg / day) with or without other secretagogue.
Inclusion Criteria - male or female (not pregnant) , aged between 35 and 65 years who present clinical symptoms of type 2 diabetes between 6 months to 10 years of disease, according to the diagnostic criteria.
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 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 % and taking metformin (dose above 1700 mg / day) with or without other secretagogue
- •Male or female (not pregnant), who present clinical symptoms of type 2 diabetes between 6 months to 10 years of disease, according to the diagnostic criteria.
排除标准
- •Patients with DM1, DM2 using insulin and other types of diabetes
- •T2DM with chronic complications that already have clinical consequences
- •Creatinine serum greater than 1.4 (female) and 1.5 mg/dl (male)
- •History of heart disease and severe concomitant diseases such as liver, coronary artery, renal, with severe psychiatric or neurological disorders
- •Patients with a history of abuse of alcohol 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 remainder 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
HbA1c - glycated haemoglobin
时间窗: 12 weeks
Fasting Glucose
时间窗: 4 weeks
Cholesterol
时间窗: 12 weeks
次要结局
未报告次要终点