A study on the effect of Dapagliflozin and Metformin combination on Insulin resistance and cardiovascular disease risk factors in subjects with type II diabetes mellitus
Phase 3
- Conditions
- Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
- Registration Number
- CTRI/2023/10/059034
- Lead Sponsor
- S Abissha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Male/female aged 18-60 years
2) Newly diagnosed with type 2 diabetes mellitus patients (FBS >126mg/dl and PPBS >200mg/dl)
3) HbA1c level 7% to 8%
4) Newly diagnosed type II diabetes with or without hypertension and dyslipidemia
Exclusion Criteria
1) Diabetes with renal failure
2) Diabetes with liver failure
3) Pregnancy and lactation, psychiatric patients
4) Age above 60 years
5) Patients who are not willing to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) TyG index, TG to HDL C ratio from baseline to 12 weeks <br/ ><br>2) Changes in FBS, PPBS & HbA1c, serum uric acid, systolic BP, body mass index, abdominal circumference, waist circumference, neck circumference, waist to hip ratio from baseline to 12 weeks <br/ ><br>Timepoint: baseline to 12 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Assessing the tolerability & safety of monotherapy and combination therapy based on patient reported outcomesTimepoint: baseline to 12 weeks