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

NCT ID: NCT05164263

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2027-08-31

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

Conditions

Type II Diabetes Mellitus; Efficacy, Self; Safety Issues

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months

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

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

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

Interventions

Empagliflozin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Getz Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Umar Wahab

Role: PRINCIPAL_INVESTIGATOR

Umar Diabetes Foundation

Locations

Kabul University of Medical Sciences(KUMS)

Kabul, Afghanistan, Afghanistan

Site Status: COMPLETED

Agha Khan univeristy hospital

Nairobi, Kenya, Kenya

Site Status: RECRUITING

Lagos University Teaching Hospital

Lagos, Nigeria, Nigeria

Site Status: RECRUITING

Umar Diabetes Foundation

Islamabad, , Pakistan

Site Status: COMPLETED

National hospital Sri Lanka

Colombo, Colombo, Sri Lanka

Site Status: COMPLETED

NHK

Kandy, Kandy, Sri Lanka

Site Status: COMPLETED

Countries

Afghanistan; Kenya; Nigeria; Pakistan; Sri Lanka

Central Contacts

Dr. Muhammad Nabeed Tahir

Role: CONTACT

nabeedt@gmail.com

+923015376299

Dr. Umar Wahab

Role: CONTACT

dromarwahab@yahoo.com

+923339158285

Facility Contacts

Dr. Saira Banu Sokwalla

Role: primary

Dr. Olufemi Adetola Fasanmade

Role: primary

References

Ferrannini E, Mark M, Mayoux E. CV Protection in the EMPA-REG OUTCOME Trial: A "Thrifty Substrate" Hypothesis. Diabetes Care. 2016 Jul;39(7):1108-14. doi: 10.2337/dc16-0330.

Reference Type: BACKGROUND

PMID: 27289126 (View on PubMed)

Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.

Reference Type: BACKGROUND

PMID: 24795251 (View on PubMed)

Other Identifiers

GTZ-DM-003-21

Identifier Type: -

Identifier Source: org_study_id