Post-approvaL, concurrent, observational Study to assess clinical effectiveness and safety ofÃ¢â?¬Â¯REmogliFlozINÃ¢â?¬Â¯In high-risk patiEnts with type 2 Diabetes Mellitus - REFINE study

Torrent Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

研究概览

暂无简介。

•1. Male or female patients 18 to 59 years.
•2. Known T2DM cases with uncontrolled HbA1c >7 % requiring or receiving Remogliflozin etabonate for not more than two weeks
•3. T2DM cases with one or more additional risk factors or established CVD that is stable for >3 months following hospitalization
•4.Patients willing follow-up for 24 W at the same centre.

•1. Hypersensitivity to SGLT2i or Metformin Extended release formulation
•2. Unstable or untreated CVD with HF not receiving either ARNI or Diuretics
•3. CKD with eGFR <45 ml/min
•4. Hepatic enzyme elevation X3 ULN
•5. DKA and/or history or prior use of Dapagliflozin or Canagliflozin or Empagliflozin
•6. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding
•7. Type 1 diabetes mellitus patients
•8. Sexually active woman of childbearing age not practicing accepted birth control method
•9. Urinary tract infection or acute pyelonephritis in the 30 days prior to study entry

发起方

Torrent Pharmaceuticals Ltd