Study of saroglitazar in treatment of prediabetes with dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in serum triglycerides
研究概览
简要总结
The preclinical and clinical studies of saroglitazar have suggested that saroglitazar is a potent triglyceride lowering agent along with significant improvement in insulin sensitivity. In various studies, saroglitazar has been found safe and well tolerated. The current study is designed to evaluate the effect of saroglitazar 4mg once daily in patients with prediabetes and dyslipidemia. This is an observational, single centre study. Subjects will be followed up for 24 weeks duration. Lipid (total cholesterol, triglycerides, VLDL-C, LDL-C, HDL-C and non HDL-C) and glycemic parameters (HbA1c) will be evaluated at baseline and at 24 weeks follo-up. Kidney and liver functions and ECG will also be done to evaluate the safety of saroglitazar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to participate in the study and follow protocol.
- •Patients of either sex with age group of 20-60 years.
- •Prediabetic patients with HbA1c 5.7- 6.5 % and deranged lipids as per NCEP guidelines.
排除标准
- •Type 1 diabetes mellitus Type 2 diabetes Secondary hypertension.
- •Bronchial asthma.
- •Chronic obstructive pulmonary disease.
- •Any other respiratory disorders.
- •g.Any Hepatic or renal diseases.
- •h.Any other cardiovascular disorder.
- •ïƒ˜Pregnant and lactating women.
- •ïƒ˜History of known allergy to drugs.
- •ïƒ˜Patient concurrently taking other medication which is known to affect the blood sugar and lipid parameters.
结局指标
主要结局
Change in serum triglycerides
时间窗: 24 weeks
次要结局
- change in HbA1c, total cholesterol, LDL-C, VLDL-C, non HDL-C, HDL-C(week 24)