A Phase IV, prospective, single arm, baseline controlled, multi-centric study for assessment of safety and efficacy of Fixed dose combination (FDC) of Remogliflozin Etabonate, Metformin and Vildagliptin (RMV) in management of Type 2 Diabetes Mellitus (T2DM) patients - TRIAD-RMV

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 215 人开始时间: 待定最近更新: 2023年10月16日

试验速览

暂无简介。

•1. Adult Indian (Age =18 years, = 65 years) of either gender, diagnosed with T2DM for more than 6 months
•2. On ongoing dual drug regimen of stable dose of Metformin+DPP4i or Metformin+SGLT2i since last 12 weeks before screening
•3. With Daily Metformin Dose on 1000mg or 2000mg
•4. Uncontrolled glycaemia with HbA1c = 8% at time of screening
•5. Patient willing to provide signed and dated, written informed consent prior to any study specific procedures

•1. H/o hypersensitivity or contraindication to the contents of the IP, (Remogliflozin Etabonate, Vildagliptin and Metformin)
•2. Patients of Type 1 diabetes.
•3. Patient suffering from any moderate to severe hepatic, cardiac, neurologic or neoplastic disorder
•4. Patients with eGFR <60 mL/min/1.73 m2 at time of initiation of Remogliflozin Etabonate (RE) therapy (eGFR of <45 L/min/1.73m2 in patients on Metformin+RE)
•5. History of pancreatitis or pancreatic surgery
•6. Patients with a history of any malignancy
•7. History of diabetic ketoacidosis
•8. Any acute/chronic systemic infections
•9. Recurrent urogenital infections
•10. Patients at risk for volume depletion as judged by the investigator
•11. Active participation in another clinical study with IP and/or investigational device
•12. For women only – currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
•13. Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance.

发起方

Glenmark Pharmaceuticals Ltd