Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
- Conditions
- Type II Diabetes MellitusEfficacy, SelfSafety Issues
- Interventions
- Registration Number
- NCT05164263
- Lead Sponsor
- Getz Pharma
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 156
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months Empagliflozin Type 2 diabetic males \& females between 18-65 years. * HbA1c: 7.0% - 10% * eGFR ˃60 mL/min/1.73m2. * Patient who will give informed consent
- Primary Outcome Measures
Name Time Method SAFETY and TOLERABILITY Outcomes 6 months Frequency of adverse events, serious adverse events during the course of study follow-up. Percentage of patients who tolerate empagliflozin.
- Secondary Outcome Measures
Name Time Method Efficacy outcomes 6 months Change from baseline in HbA1c% and fasting plasma glucose to the last-observation on treatment. Change from baseline in bodyweight \& other study parameters.
Trial Locations
- Locations (3)
NHK
🇱🇰Kandy, Sri Lanka
Umar Diabetes Foundation
🇵🇰Islamabad, Pakistan
NHSL
🇱🇰Colombo, Sri Lanka