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
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