Actively Recruiting
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Led by Getz Pharma · Updated on 2026-01-22
2000
Participants Needed
6
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with Type II Diabetes Mellitus aged 18 to 65 years
- HbA1C between 7% and 10%
- Uncontrolled on oral antidiabetics and lifestyle modification for at least 3 months
- Never used Empagliflozin before
- Estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73m2 or higher
- Able to give informed consent
You will not qualify if you...
- Diagnosis of Type 1 diabetes
- History of recurrent urinary tract infections or fungal infections
- Renal or hepatic dysfunction with abnormal renal function test or urine routine examination
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state
- Severe hypoglycemia
- Pregnant or lactating women
- Pancreatitis or any serious complications
- Known hypersensitivity to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Kabul University of Medical Sciences(KUMS)
Kabul, Afghanistan, Afghanistan
Completed
2
Agha Khan univeristy hospital
Nairobi, Kenya, Kenya
Actively Recruiting
3
Lagos University Teaching Hospital
Lagos, Nigeria, Nigeria
Actively Recruiting
4
Umar Diabetes Foundation
Islamabad, Pakistan
Completed
5
National hospital Sri Lanka
Colombo, Colombo, Sri Lanka
Completed
6
NHK
Kandy, Kandy, Sri Lanka
Completed
Research Team
D
Dr. Muhammad Nabeed Tahir
CONTACT
D
Dr. Umar Wahab
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here