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Site",{"type":94,"coordinates":1114},[1108,1109],{"lat":1109,"lon":1108},{"facility":1117,"status":40,"city":1118,"state":40,"zip":40,"country":1091,"countryCode":1092,"cosmosGeoPoint":1119,"geoPoint":1121,"contacts":40},"1276.10.38005 Boehringer Ingelheim Investigational Site","Kyiv",{"type":94,"coordinates":1120},[1108,1109],{"lat":1109,"lon":1108},{"type":1123,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[1125],{"name":1126,"class":6},"Eli Lilly and Company","100182383","phase-2-a-16-weeks-study-on-efficacy-and-safety-of-two-doses-of-empagliflozin-bi-10773-once-daily-versus-twice-daily-in-patients-with-type-2-diabetes-mellitus-and-preexisting-metformin-therapy-100182383",true,"NCT01649297","A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy","A Randomised, Double 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Glycated hemoglobin (HbA1c) \\>=7.0 and \\\u003C=10\u002F0% at Visit 1\n3. Metformin therapy (at least 1500 mg\u002Fday, BID)\n4. age\\>=18 at Visit 1\n5. body mass index \\\u003C=45 kg\u002Fm2\n\nExclusion criteria:\n\n1. estimated creatinine clearance rate (eCCr) \\\u003C60 ml\u002Fmin (Cockcroft-Gault formula) screening and\u002For run-in\n2. a confirmed glucose level \\>240 mg\u002Fdl (\\>13.3 mmol\u002FL) after an overnight fast during placebo run-in",false,"ALL","18 Years",{"count":1138,"type":1139},983,"ACTUAL","INTERVENTIONAL",[1142],"PHASE2","The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.",[1145],"Diabetes Mellitus, Type 2","COMPLETED","2015-06-26",{"date":1149,"type":1150},"2015-07-23","ESTIMATED",{"date":1152,"type":40},"2012-10",{"date":1154,"type":1139},"2013-12",{"name":5,"class":6},139]