[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451881":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":108,"collaborators":20,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":20,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":20,"overallStatus":51,"whyStopped":20,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Getz Pharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months","EXPERIMENTAL","Type 2 diabetic males \\& females between 18-65 years.\n\n* HbA1c: 7.0% - 10%\n* eGFR ˃60 mL\u002Fmin\u002F1.73m2.\n* Patient who will give informed consent",[13],"Drug: Empagliflozin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Umar Wahab","Umar Diabetes Foundation","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Dr. Muhammad Nabeed Tahir","CONTACT","+923015376299","nabeedt@gmail.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Dr. Umar Wahab","+923339158285","dromarwahab@yahoo.com",[37,49,63,81,90,100],{"facility":38,"status":39,"city":40,"state":41,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":20},"Kabul University of Medical Sciences(KUMS)","COMPLETED","Kabul","Afghanistan","AF",{"type":44,"coordinates":45},"Point",[46,47],69.17233,34.52813,{"lat":47,"lon":46},{"facility":50,"status":51,"city":52,"state":53,"zip":20,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Agha Khan univeristy hospital","RECRUITING","Nairobi","Kenya","KE",{"type":44,"coordinates":56},[57,58],36.81667,-1.28333,{"lat":58,"lon":57},[61],{"name":62,"role":29,"phone":20,"phoneExt":20,"email":20},"Dr. Saira Banu Sokwalla",{"facility":64,"status":51,"city":65,"state":66,"zip":20,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Lagos University Teaching Hospital","Lagos","Nigeria","NG",{"type":44,"coordinates":69},[70,71],3.39467,6.45407,{"lat":71,"lon":70},[74,76,79],{"name":75,"role":29,"phone":20,"phoneExt":20,"email":20},"Dr. Olufemi Adetola Fasanmade",{"name":77,"role":78,"phone":20,"phoneExt":20,"email":20},"Dr. Andrew Enemako Uloko","SUB_INVESTIGATOR",{"name":80,"role":78,"phone":20,"phoneExt":20,"email":20},"Dr. Chioma Nnachukwu",{"facility":24,"status":39,"city":82,"state":20,"zip":20,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":20},"Islamabad","Pakistan","PK",{"type":44,"coordinates":86},[87,88],73.04329,33.72148,{"lat":88,"lon":87},{"facility":91,"status":39,"city":92,"state":92,"zip":20,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":20},"National hospital Sri Lanka","Colombo","Sri Lanka","LK",{"type":44,"coordinates":96},[97,98],79.84868,6.93548,{"lat":98,"lon":97},{"facility":101,"status":39,"city":102,"state":102,"zip":20,"country":93,"countryCode":94,"cosmosGeoPoint":103,"geoPoint":107,"contacts":20},"NHK","Kandy",{"type":44,"coordinates":104},[105,106],80.6336,7.2906,{"lat":106,"lon":105},{"type":109,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100451881","phase-4-real-world-safety--efficacy-experience-of-empagliflozin-with-or-without-metformin-in-t2dm-patients---ease-study-100451881",false,"NCT05164263","Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study","Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in Patients With Type II Diabetes Mellitus","EASE","Inclusion Criteria:\n\nPatient 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\u002Fmin\u002F1.73m2.\n\nExclusion Criteria:\n\nType 1 diabetes, History of recurrent urinary tract infection (UTI), fungal infection, renal and\u002For hepatic dysfunctions, where RFT and Urine R\u002FE is abnormal, Diabetic Ketoacidosis and\u002For hyperosmolar hyperglycemic state, severe hypoglycemia, Pregnant or lactating women, Pancreatitis, any serious complications or hypersensitivity.",true,"ALL","18 Years","65 Years",{"count":123,"type":124},2000,"ESTIMATED","INTERVENTIONAL",[127],"PHASE4","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.\n\nStudy design Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.\n\nSample 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).\n\nFollow up visits: After recruitment, patient is supposed to have three visits for follow-ups.\n\nVisit 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.\n\nLABORATORY TESTING:\n\nReputable Lab is considered for laboratory testing of diabetes patients i.e. HbA1C%, FBG, RFT and urine R\u002FE. 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.\n\nWhere in Urine Routine Examination (Urine R\u002FE), we consider as follows:\n\n* Visual Examination:\n\n  * Urine color: Normal (Yellow), Pale Yellow, Dark Yellow, Brown, Red or Pink or any other.\n  * Urine clarity: Clear, slightly Cloudy, cloudy or turbidity\n* Chemical Examination:\n\n  * Specific gravity\n  * pH\n  * Bilirubin\n  * Urobilinogen\n  * Protein\n  * Ketone\n  * Leukocyte Esterase\n* Microscopic Examination:\n\n  * Red Blood Cells:\n  * Epithelial Cells:\n  * Amorphous:\n  * Pus Cells\n  * Bacteria\n  * Yeast\n  * Casts\n  * Crystals\n\nWhere in Renal Function Test (RFT), we consider as follows:\n\n* Blood Urea Nitrogen (BUN): mg\u002FdL\n* Serum Creatinine: mg\u002FdL\n* Estimated Glomerular Filtration Rate (eGFR): mL\u002Fmin\u002F1.73 m2",[130,131,132],"Type II Diabetes Mellitus","Efficacy, Self","Safety Issues","2026-01-20",{"date":135,"type":136},"2026-01-22","ACTUAL",{"date":138,"type":136},"2021-04-01",{"date":140,"type":124},"2027-08-31",{"name":5,"class":6},6]