CTRI/2014/10/005131已完成4 期
Comparison of effectiveness and safety of add on therapy of saroglitazar and fenofibrate with metformin in Indian patients with type 2 diabetes mellitus and predominant hypertriglyceridemia
Dr Pranab Kumar Sahana1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年7月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in TG
研究概览
简要总结
Diabetes have increased cardiovascular risk. The risk is exaggerated by dyslipidemia. Saroglitazar is the first dual PPAR alfa/gamma agonist for patients suffering from diabetic dyslipidemia.
Present study is designed to compare the effectiveness and safety of add on therapy of saroglitazar and fenofibrate with metformin in Indian patients with diabetic dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Newly diagnosed cases of type 2 diabetes mellitus with predominant hypertriglyceridemia 2.Plasma triglyceride level ≥ 150 mg/dl 3.HbA1C ≥ 6.5 & ≤ 8.
排除标准
- •1Female patients who are pregnant or lactating 2.Patients on any oral anti-diabetic drug 3.FPG > 250mg/dl, PPPG > 350mg/dl, LDL-C > 130 mg/dl 4.Co-morbid cardiovascular, renal and psychiatric diseases 5.Co-administration of drugs that are likely to interact with saroglitazar, fenofibrate or metformin and drugs that are likely to alter lipid profile and glycemic status 6.Past history of cardiovascular disease 7.Patients with rising FPG and PPPG levels at week 4 or 8.
结局指标
主要结局
Change in TG
时间窗: At week 12 visit
次要结局
- Change in TC, HDL, LDL, HbA1C, FPG & PPPG(At week 12)
研究者
研究点 (1)
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