To check the effect of sitagliptin dapagliflozin & metformin combination medicine on continuous glucose monitoring in type 2 diabetic patients with heart disease
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2023/11/059753
- 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
Male or female patients 18 to 59 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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MAGE or AUC more than 180 mg per dl on Day 14 plus or minus 2 <br/ ><br> <br/ ><br>TIR percentage on Day 14 plus or minus 2 <br/ ><br> <br/ ><br>HbA1c assessment on Day 90 plus or minus 2 <br/ ><br> <br/ ><br>Percent responder rate for cases achieving target HbA1c less than or equal to 7 <br/ ><br>percentage on Day 90 plus or minus two <br/ ><br> <br/ ><br>Assessment of 24 hr glucose profile using CGM machine to assess the AUC <br/ ><br> <br/ ><br>Time in Range TIR <br/ ><br>Assessment of 24 hr glucose profile using CGM machine to assess the AUC <br/ ><br>Time in Range TIRTimepoint: Baseline to 14 plus minus 2 days followup <br/ ><br> <br/ ><br>Baseline to 14 plus minus 2 days followup <br/ ><br> <br/ ><br>Baseline to 90 plus minus days followup <br/ ><br> <br/ ><br>Baseline to 90 plus minus 2 days followup <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method TIR percentage on Day 90 plus minus 2 <br/ ><br> <br/ ><br>Percent cases with TAR percentage greater then 180 mg per dl on Day 14 plus minus 2 <br/ ><br> <br/ ><br>Percent cases with TBR percentage less then 70 mg per dl on Day 14 plus minus 2 <br/ ><br> <br/ ><br>Percent cases with TBR percentage less then 54 mg per dl on Day 14 plus minus 2 <br/ ><br> <br/ ><br>Weight D on Day 90 plus minus 2 <br/ ><br> <br/ ><br>Treatment emergent adverse events TEAE on Day 90 plus minus 2Timepoint: Baseline to 90 plus minus 2 days followup <br/ ><br> <br/ ><br>Baseline to 14 plus minus 2 days followup <br/ ><br> <br/ ><br>Baseline to 14 plus minus days followup <br/ ><br> <br/ ><br>Baseline to 14 plus minus 2 days followup <br/ ><br> <br/ ><br>Baseline to 90 plus minus days followup <br/ ><br> <br/ ><br>Baseline to 90 plus minus 2 days followup