Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Study Details
Study Description
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:
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Visual Examination:
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Urine color: Normal (Yellow), Pale Yellow, Dark Yellow, Brown, Red or Pink or any other.
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Urine clarity: Clear, slightly Cloudy, cloudy or turbidity
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Chemical Examination:
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Specific gravity
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pH
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Bilirubin
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Urobilinogen
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Protein
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Ketone
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Leukocyte Esterase
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Microscopic Examination:
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Red Blood Cells:
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Epithelial Cells:
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Amorphous:
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Pus Cells
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Bacteria
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Yeast
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Casts
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Crystals
Where in Renal Function Test (RFT), we consider as follows:
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Blood Urea Nitrogen (BUN): mg/dL
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Serum Creatinine: mg/dL
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Estimated Glomerular Filtration Rate (eGFR): mL/min/1.73 m2
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: 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
|
Outcome Measures
Primary Outcome Measures
- SAFETY and TOLERABILITY Outcomes [6 months]
Frequency of adverse events, serious adverse events during the course of study follow-up. Percentage of patients who tolerate empagliflozin.
Secondary Outcome Measures
- Efficacy outcomes [6 months]
Change from baseline in HbA1c% and fasting plasma glucose to the last-observation on treatment. Change from baseline in bodyweight & other study parameters.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Umar Diabetes Foundation | Islamabad | Pakistan |
Sponsors and Collaborators
- Getz Pharma
Investigators
- Principal Investigator: Umar Wahab, Umar Diabetes Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- GTZ-DM-003-21