Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population.
Study design Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.
Sample size The estimated sample size will be n=156. Duration of study 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) Safety Assessment: Patient will be monitored for Hypoglycemia, Dehydration, Hypotension, Urinary Tract Infections, Fungal Infections, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion and Other side effects (if any).
Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups.
Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy.
LABORATORY TESTING:
Reputable Lab is considered for laboratory testing of diabetes patients i.e. HbA1C%, FBG, RFT and urine R/E. The certified clinical lab will be responsible for receiving and analyzing clinical sample. Patients will have special discount of upto 50% for study related laboratory investigations.
Where in Urine Routine Examination (Urine R/E), we consider as follows:
* Visual Examination:
* Urine color: Normal (Yellow), Pale Yellow, Dark Yellow, Brown, Red or Pink or any other.
* Urine clarity: Clear, slightly Cloudy, cloudy or turbidity
* Chemical Examination:
* Specific gravity
* pH
* Bilirubin
* Urobilinogen
* Protein
* Ketone
* Leukocyte Esterase
* Microscopic Examination:
* Red Blood Cells:
* Epithelial Cells:
* Amorphous:
* Pus Cells
* Bacteria
* Yeast
* Casts
* Crystals
Where in Renal Function Test (RFT), we consider as follows:
* Blood Urea Nitrogen (BUN): mg/dL
* Serum Creatinine: mg/dL
* Estimated Glomerular Filtration Rate (eGFR): mL/min/1.73 m2