Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05164263

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

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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

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