Dapagliflozin Efficacy & Safety as Mono or Combination therapy in reduction of HbA1C and Body Weight in Type II Diabetes Mellitus Patients.
Not Applicable
- Conditions
- Type 2 Diabetes Mellitus.Type 2 Diabetes mellitus
- Registration Number
- IRCT20170614034526N5
- Lead Sponsor
- Hilton Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Male & Female (Non-pregnant) Patients = 18 years of age with type II Diabetes Mellitus.
Type II diabetes mellitus patients having controlled diabetes HbA1C 7-10 % or uncontrolled diabetes (HbA1C 10-12%).
Patients having BMI of > 25 kg/m2.
Not Hypersensitive to Dapagliflozin or any of ingredients.
Exclusion Criteria
Male & Female Type I Diabetes patients.
Patients having complaints of urinary tract infections, genital infections
Patients with e GFR < 60 mL/min/1.73 m².
Pregnant Females.
Patients with end stage renal disease, or going through dialysis.
Suspected Ketoacidosis patients.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in HbA1c. Timepoint: measured at week 12 & week 24. Method of measurement: Hba1C test.;Body Weight Reduction. Timepoint: week 02, 04, 12 & week 24. Method of measurement: Physical Measurement.
- Secondary Outcome Measures
Name Time Method Serious adverse events (SAE) and non-serious adverse events will be observed. An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the procedure. Timepoint: At Week 04, 12 & 24. Method of measurement: Clinical Examination.