RecruitingPhase 4NCT05164263

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

Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in Patients With Type II Diabetes Mellitus


Sponsor

Getz Pharma

Enrollment

2,000 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial studies how well empagliflozin (with or without metformin) works and how safe it is for people with type 2 diabetes in the real world. **You may be eligible if...** - You are 18–65 years old with type 2 diabetes - Your HbA1c is between 7% and 10% - Your diabetes has not been well-controlled despite oral medications and lifestyle changes for at least 3 months - You have never taken empagliflozin before - Your kidney function is adequate (eGFR above 60) **You may NOT be eligible if...** - You have type 1 diabetes - You have a history of frequent urinary or fungal infections - You have kidney or liver problems - You have had diabetic ketoacidosis or severe low blood sugar - You are pregnant or breastfeeding - You have pancreatitis or serious complications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin

Empagliflozin + Metformin (Diampa™-M): 5mg+500mg, 5mg+850mg, 5mg+1000mg, 12.5mg+1000mg, 12.5mg+500mg, 12.5mg+ 850mg Empagliflozin Alone (Diampa™): 10mg, 25mg


Locations(6)

Kabul University of Medical Sciences(KUMS)

Kabul, Afghanistan, Afghanistan

Agha Khan univeristy hospital

Nairobi, Kenya, Kenya

Lagos University Teaching Hospital

Lagos, Nigeria, Nigeria

Umar Diabetes Foundation

Islamabad, Pakistan

National hospital Sri Lanka

Colombo, Colombo, Sri Lanka

NHK

Kandy, Kandy, Sri Lanka

View Full Details on ClinicalTrials.gov

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NCT05164263


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