Post Approval Concurrent Observational Study to Assess Safety Clinical Utilization and Effectiveness of Vildagliptin and Dapagliflozin Fixed Dose Combination (FDC) in the treatment of Type 2 Diabetes with Multiple Risk Factors - SUVIDA MRF - SUVIDA

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 greater than 7 requiring Dapagliflozin or Vildagliptin SR
•as fixed dose combination
•3. T2DM cases with one or more additional risk factors or established CAD that is stable for greater then 3 months following hospitalization
•4. Patients willing follow-up for 12 W at the same centre

•1. Hypersensitivity to SGLT2i or Metformin Extended release formulation
•2. Unstable or untreated CAD with HF not receiving either ARNI or Diuretics
•3. CKD with eGFR less than 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 breastfeeding
•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