CTRI/2021/04/032550尚未招募未知
A Randomised Controlled study of efficacy and safety of Saroglitazar in Type 2 Diabetis Mellitus
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age 18 â?? 65yr.
- •2.Diagnosis of type 2 diabetes mellitus as per ADA criteria.
- •3.On lifestyle modifications and on metformin; vildagliptin medications for 3 months.
- •4.HbA1C >7%
排除标准
- •1.Patient who had any clinically significant or unstable medical or Psychiatric illness.
- •2.History of cardiac diseases (NYHA grade 3 â?? 4) or cardiac anomalies.
- •3.Patient on glitazone/glitazar for >30days.
- •4.History of Renal insufficiency - serum creatinine >=1.8mg/dl.
- •5.Patient with history of significant hepatic impairment (serum bilirubin >2 times, AST, ALT and alkaline phosphatase >3 times the upper limit of normal).
- •6.Patient have history of uncontrolled hypertension.
- •7.Patient have any malignancy and Patient have any h/o substance abuse (alcohol/drugs).
- •8.Pregnant & Lactating Woman and Patient with history of allergy/intolerance.
研究者
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