Efficacy and safety of saroglitazar as add-on therapy on glycemic status in patients with type 2 diabetes mellitus: A randomized, double blind placebo controlled trial - NI

JIPMER Intramural fund0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

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•Patients with type 2 diabetes mellitus diag-nosed by American Diabetes Association (ADA) criteria within the past 3 months to 10 years, on stable dose of metformin with or without sulfonylureas, for at least past 2 months, with HbA1C of 7% - 8%

•Liver dysfunction (AST, ALT > 2 times the upper limit of normal)
•Renal dysfunction (GFR <60 ml/min/1.73 m2)
•Patient with concurrent illnesses like CAD (Coronary Artery Disease), CVA ( cerebro-vascular accidents), PVD(Peripheral Vascular Disease), CKD (Chronic Kidney Disease) other than hypertension
•Patients taking anti diabetic drugs other than metformin and sulfonylureas
•Pregnant women or lactating mothers; women in reproductive age group not practicing contraceptive measures.
•Patients who had participated in other trials in the past three months.
•Patients with active infections such as diabet-ic foot infection, etc
•Patients not willing / able to perform bicycle ergometer.
•Patients with Asthma, COPD, active tubercu-losis and history of acute respiratory infection in the last 1 month.

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JIPMER Intramural fund