A Multicentric Active Post Marketing Surveillance Study to Evaluate the Safety and Tolerability of Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients - NA

Abbott Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

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•The inclusion criteria are in accordance with the approved prescribing information and the subjects meeting all of the criteria will be included:
•1.Male and female patients above 18 years of age.
•2.Type 2 diabetes mellitus patients prescribed Vildagliptin 100mg SR once daily formulation by the treating physician as per the approved prescribing information and in accordance with the clinical practice.
•3.Patients willing to sign patient authorization form (PAF)

•The exclusion criteria are in accordance with the approved prescribing information and
•the subjects meeting any of the criteria will be excluded:
•1. Known case of type 1 Diabetes Mellitus (DM)
•2. Known history of any acute metabolic diabetic complications such as ketoacidosis
•3. Patients with known history of heart failure NYHA functional class IV
•4. Patients with known history of hepatic impairment including patients with a pre treatment ALT or AST >2.5X the upper limit of normal
•5. Patients with known history of moderate or severe renal impairment or End Stage
•Renal Disease (ESRD)
•6. Patient with known hypersensitivity to Vildagliptin or to any of the excipients

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