Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients 18 to 75 years Known T2DM cases with at least one additional vascular complication uncontrolled on Metformin ER receiving concomitant DPP4i or Glimepiride not more than 2 mg per day with HbA1c more than 7 percent but less than or equal to 8 point 5 percent T2DM cases with additional one CV risk factor Hypertension Smoking Dyslipidemia BMI less than 23 and or vascular complications Nephropathy Neuropathy Retinopathy or LVD Patients willing for follow up for 1 and 2 and 13 week at the same center
Exclusion criteria
Exclusion criteria: Hypersensitivity to Sitagliptin or Dapagliflozin or Metformin or formulation excipients T2D with uncontrolled vascular complications including LVD NYHA IV Heart failure or ACS less than 2 months post PCI Hepatic enzyme elevation X3 ULN and CKD Stage 3b 4 and 5 For women only currently pregnant confirmed with positive pregnancy test or breastfeeding Type 1 diabetes mellitus patients Sexually active woman of childbearing age not practicing accepted birth control method
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MAGE or AUC more than 180 mg per dl on Day 14 plus or minus 2 TIR percentage on Day 14 plus or minus 2 HbA1c assessment on Day 90 plus or minus 2 Percent responder rate for cases achieving target HbA1c less than or equal to 7 percentage on Day 90 plus or minus two Assessment of 24 hr glucose profile using CGM machine to assess the AUC Time in Range TIR Assessment of 24 hr glucose profile using CGM machine to assess the AUC Time in Range TIRTimepoint: Baseline to 14 plus minus 2 days followup Baseline to 14 plus minus 2 days followup Baseline to 90 plus minus days followup Baseline to 90 plus minus 2 days followup | — |
Secondary
| Measure | Time frame |
|---|---|
| TIR percentage on Day 90 plus minus 2 Percent cases with TAR percentage greater then 180 mg per dl on Day 14 plus minus 2 Percent cases with TBR percentage less then 70 mg per dl on Day 14 plus minus 2 Percent cases with TBR percentage less then 54 mg per dl on Day 14 plus minus 2 Weight D on Day 90 plus minus 2 Treatment emergent adverse events TEAE on Day 90 plus minus 2Timepoint: Baseline to 90 plus minus 2 days followup Baseline to 14 plus minus 2 days followup Baseline to 14 plus minus days followup Baseline to 14 plus minus 2 days followup Baseline to 90 plus minus days followup Baseline to 90 plus minus 2 days followup | — |
Countries
India
Contacts
Public ContactDr Krishnaprasad K
Hope and Care Centre Mumbai
Outcome results
None listed