Study to check the result and safety of combination treatment of vildagliptin and dapagliflozin in type 2 diabetes mellitus patient
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2022/08/044757
- Lead Sponsor
- Torrent Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method