Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
None listed
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients 18 to 59 years 2.Known T2DM cases with uncontrolled HbA1c >7 % requiring Dapagliflozin/Sitagliptin as fixed dose combination 3.T2DM cases with one or more additional risk factors or ASCVD that is stable for >3 months following hospitalization 4.Patients willing follow-up for 12 W at the same centre
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean changes from baseline in glycated hemoglobin (HbA1c) level at 12 WeeksTimepoint: Mean changes from baseline in glycated hemoglobin (HbA1c) level at 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of participants with treatment emergent adverse event during observation period 2.Change for HbA1c in T2D cases with ASCVD at 12 Weeks 3.Change in Albumin & LDL-C at 12 Weeks 4.Change in FPG and PPBG at 4 WeeksTimepoint: Baseline (day 0) to 12 weeks Baseline (day 0) to 12 weeks Baseline (day 0) to 12 weeks Baseline (day 0) to 4 weeks | — |
Countries
India
Contacts
Public ContactDr Krishnaprasad K
Torrent Pharmaceuticals Ltd
Outcome results
None listed