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Taking peoplePhase 4

Studies empagliflozin safety with or without metformin in adults with type 2 diabetes

Checks side effects of empagliflozin, with or without metformin, in adults with type 2 diabetes.

Key facts

Who runs it
Getz Pharma
Where
Colombo and Kandy, Sri LankaSee the 2 sitesAlso in 4 other countries, 4 sites
Trial code
Registry title
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Status
Recruiting
Phase
Phase 4
People taking part
2,000 people, planned
Started
1 Apr 2021
Expected to end
31 Aug 2027
Type of study
Interventional
Treatments tested
  • Empagliflozin
Record updated
22 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with type 2 diabetes whose blood sugar is still too high on diabetes tablets and lifestyle changes, and who have never taken empagliflozin.

Age
18 to 65 years
Sex
All sexes
Disease stage
Type 2 diabetes with HbA1C 7% (53 mmol/mol) - 10% (86 mmol/mol), not controlled on oral antidiabetic medicines and lifestyle changes for at least 3 months. eGFR above 60 mL/min/1.73m2.
Earlier treatment
Must have taken oral antidiabetic medicines and made lifestyle changes for at least 3 months. Must not have taken empagliflozin before.
Biomarker or test result
HbA1C 7% (53 mmol/mol) - 10% (86 mmol/mol); eGFR above 60 mL/min/1.73m2.

Main reasons for not taking part

  • Type 1 diabetes
  • History of repeated urinary tract infection or fungal infection
  • Kidney or liver problems, or abnormal kidney function test or urine test
  • Diabetic ketoacidosis or hyperosmolar hyperglycemic state, or severe low blood sugar
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Sri Lanka

Also in 4 other countries, 4 sites

  • National hospital Sri LankaColombo, Sri LankaContact: Dr. Muhammad Nabeed TahirNo longer taking part
  • NHKKandy, Sri LankaContact: Dr. Muhammad Nabeed TahirNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The group in the trial

  • Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 monthsTreatment being tested

    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

    Treatment: Empagliflozin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in Patients With Type II Diabetes Mellitus
Plain-language title
Studies empagliflozin safety with or without metformin in adults with type 2 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05164263, who can take part
Record updated
22 January 2026