Type II Diabetes MellitusPhase 4EASENCT05164263
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
A Phase 4 study testing Empagliflozin in people with Type II Diabetes Mellitus and Efficacy, Self, run by Getz Pharma at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus, Efficacy, Self, Safety Issues
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 Apr 2021to 31 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
Sri Lanka2 sites
- Completed
National hospital Sri Lanka
Colombo, Colombo
- Completed
NHK
Kandy, Kandy
Afghanistan1 site
- Completed
Kabul University of Medical Sciences(KUMS)
Kabul, Afghanistan
Kenya1 site, 1 recruiting
- Recruiting
Agha Khan univeristy hospital
Nairobi, Kenya
Dr. Saira Banu Sokwalla
Nigeria1 site, 1 recruiting
- Recruiting
Lagos University Teaching Hospital
Lagos, Nigeria
Dr. Olufemi Adetola Fasanmade
Dr. Andrew Enemako Uloko
About this study
Official title: Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in Patients With Type II Diabetes Mellitus
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.
Read more
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
- Being tested
- Empagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Empagliflozin + Metformin (Diampa™-M): 5mg+500mg, 5mg+850mg, 5mg+1000mg, 12.5mg+1000mg, 12.5mg+500mg, 12.5mg+ 850mg Empagliflozin Alone (Diampa™): 10mg, 25mg
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months | Experimental | 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 Receives: Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAFETY and TOLERABILITY Outcomes
Frequency of adverse events, serious adverse events during the course of study follow-up. Percentage of patients who tolerate empagliflozin.
Measured: 6 months
Secondary outcomes (1)
Efficacy outcomes
Change from baseline in HbA1c% and fasting plasma glucose to the last-observation on treatment. Change from baseline in bodyweight \& other study parameters.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Umar Wahab, Principal investigator, Umar Diabetes Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164263
- Sponsor's protocol ID
- GTZ-DM-003-21
- Acronym
- EASE
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request
Publications
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.
PubMed 27289126Barnett 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.
PubMed 24795251
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in Patients With Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05164263
- Acronym / sponsor ID
- EASE / GTZ-DM-003-21
- Conditions
- Type II Diabetes Mellitus, Efficacy, Self, Safety Issues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months | Experimental | Drug: EmpagliflozinType 2 diabetic males \& females between 18-65 years. * HbA1c: 7.0% - 10% * eGFR ˃60 mL/min/1.73m2. * Patient who will give informed consent |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinEmpagliflozin + Metformin (Diampa™-M): 5mg+500mg, 5mg+850mg, 5mg+1000mg, 12.5mg+1000mg, 12.5mg+500mg, 12.5mg+ 850mg Empagliflozin Alone (Diampa™): 10mg, 25mg | Drug | Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months |
Primary outcome
SAFETY and TOLERABILITY Outcomes
Time frame: 6 months
Frequency of adverse events, serious adverse events during the course of study follow-up. Percentage of patients who tolerate empagliflozin.
1 secondary outcome
Efficacy outcomes
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 27289126Ferrannini 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.
- Background: PubMed 24795251Barnett 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.
- Individual participant dataSharing planned: No. Upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Umar Wahab principal investigator
Umar Diabetes Foundation
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin in people with Type II Diabetes Mellitus and Efficacy, Self, run by Getz Pharma at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sri Lanka, Afghanistan, Kenya, Nigeria, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Muhammad Nabeed Tahir (+923015376299, nabeedt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAFETY and TOLERABILITY Outcomes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05164263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.