Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Dapagliflozin: 10 mg OD, oral for 12 weeks
Control Intervention1: Vildagliptin: 50 mg OD, oral for 12 weeks
Sponsors
Dr Ayyappan J
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult patients (Age more than or equal to 18 years) 2.Patients with Type 2 Diabetes who had Glycated Hemoglobin (HbA1C) level within 7.0 - 9.0% 3.Patient receiving add on therapy of either Dapagliflozin 10 mg or Vildagliptin 50 mg 4.Patient willing to give informed consent
Exclusion criteria
Exclusion criteria: 1.Significant Renal impairment (estimated Glomerular Filtration Rate less than 30 ml/min) 2.Ischemic Heart Disease which includes post Myocardial Infarction (NSTEMI and STEMI), Unstable Angina, post coronary revascularization and Heart failure patients 3.Diabetes patients on Insulin 4.Uncontrolled chronic Infection (i.e. chronic diabetic foot infection) 5.Planned Surgical intervention 6.Pregnancy and Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome includes Changes in the Cardiometabolic parameters such as Body weight (Kg), BMI(Kg/m ), Blood pressure (mmHg), Lipid profile(mg/dl) and Blood Glucose(mg/dl) in Diabetes patientsTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome includes the nature of adverse effects of Dapagliflozin and Vildagliptin in the study populationTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Nalini GK
Shri Atal Bihari Vajpayee Medical College and Research Institute
Outcome results
None listed