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

RecruitingPhase 4Ages 18 Years - 65 YearsAllGetz Pharma
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In plain words

What the trial is, and whether it could suit you

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 init

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 หƒ60 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.
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What it tests

  • Empagliflozin
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Where

6 sites
Kabul University of Medical Sciences(KUMS)
Kabul, Afghanistan
Agha Khan univeristy hospital
Nairobi, Kenya
Lagos University Teaching Hospital
Lagos, Nigeria
Umar Diabetes Foundation
Islamabad, Pakistan
National hospital Sri Lanka
Colombo, Sri Lanka
NHK
Kandy, Sri Lanka
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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