Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study

• Status: Active, not recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Getz Pharma
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

Patient with T2DM between 18 to 65 years with HbA1C 7% - 10%, who can give informed consent. Patient uncontrolled on oral antidiabetics and lifestyle modification for at least 3 months. Patient who are empagliflozin naive. eGFR ˃60 mL/min/1.73m2.

Exclusion Criteria:

Type 1 diabetes, History of recurrent urinary tract infection (UTI), fungal infection, renal and/or hepatic dysfunctions, where RFT and Urine R/E is abnormal, Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state, severe hypoglycemia, Pregnant or lactating women, Pancreatitis, any serious complications or hypersensitivity.