Active post marketing surveillance of FDC of Evogliptin 5mg and Metformin hydrochloride IP (SR) 1000 mg film coated bilayered tablet

Alkem Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male/ Female Patients above 18 years of age.
•2. Patients with type 2 diabetes mellitus, receiving FDC of Evogliptin 5mg + Metformin hydrochloride IP (SR) 1000 mg film coated bilayered tablet.

•1. Type I DM
•2. Patients with history of hypersensitivity to DPP-IV inhibitors/ Evogliptin and or metformin
•3. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.
•4. Pregnant or lactating female.
•5. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.
•6. Patients with moderate (stage 3b) and severe renal disorders (CrCl < 45 ml/min or GFR < 45 ml/min/1.73 m2) and patients with renal disorders or renal impairment (with serum creatinine level greater than or equal to 1.5 mg/dL for male, greater than or equal to 1.4 mg/dL for female, or abnormal creatinine clearance rate) which may result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia
•7. Patients with congestive heart failure requiring pharmacologic management

发起方

Alkem Laboratories Limited