Active Post Marketing Surveillance Study to Evaluate the Safety & Efficacy of Vildagliptin Sustained Release Tablets 100 mg. ?

Eris Lifesciences Ltd.0 个研究点目标入组 205 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•1. Male or female patients aged 18 years and above.
•2. Patients diagnosed with type 2 diabetes mellitus and who require treatment with Vildagliptin Sustained Release Tablets 100 mg as part of their routine treatment regimen.
•3. Patient with ability to understand and provide written, signed and dated informed consent form.

•1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
•2. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
•3. Patients with history of intolerance, contraindication or potential allergy/hypersensitivity to DPP-4 inhibitors.
•4. Patients with history of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at baseline visit.
•5. Patients with history of clinically significant impaired hepatic function at baseline visit.
•6. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
•7. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods during the study.
•8. Patients with history of congestive heart failure requiring pharmacologic management.
•9. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.

发起方

Eris Lifesciences Ltd.