Health Condition 1: E119- Type 2 diabetes mellitus without 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 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.
Exclusion criteria
Exclusion criteria: 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 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 WTimepoint: Mean changes from baseline in glycated hemoglobin (HbA1c) level at 12 W | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with treatment emerging adverse events during observational period. 2. Change of HbA1c in T2d cases with more than or is equal to 1 additional risk factor at 12 W. 3. Change of HbA1c in in T2d cases with CVD at 12 W. 4. Change in SBP and DBP at 12W and 24 W. 5. Change in PPBG at 12W.Timepoint: At 12 W and 24 W. | — |
Countries
India
Contacts
Public ContactDr Krishnaprasad K
Torrent Pharmaceuticals Ltd
Outcome results
None listed