[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100145503":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":11,"locations":27,"responsibleParty":41,"collaborators":43,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":11,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dapagliflozin (T2DM)","ACTIVE_COMPARATOR",null,[13],"Drug: Dapagliflozin",{"label":15,"type":10,"description":11,"interventionNames":16},"Dapagliflozin (Healthy Subjects)",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Dapagliflozin","Tablets, Oral, 10 mg, Once daily, 7 days",[15,9],[24],{"name":25,"affiliation":25,"role":26},"Bristol-Myers Squibb","STUDY_DIRECTOR",[28],{"facility":29,"status":11,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":11},"Profil Institute For Clinical Research, Inc.","Chula Vista","California","91911","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-117.0842,32.64005,{"lat":39,"lon":38},{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[44],{"name":25,"class":6},"100145503","phase-1-characterization-of-the-kinetics-of-renal-glucose-reabsorption-in-response-to-dapagliflozin-in-healthy-subjects-and-in-subjects-with-type-2-diabetes-mellitus-t2dm-100145503",false,"NCT01165268","Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)","Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus","Inclusion criteria for T2DM\n\n* Diagnosis of T2DM\n* Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin\n* Subjects taking metformin, and\u002For sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration\n* Must have a fasting plasma glucose concentration ≤ 200 mg\u002Fdl, and HbA1C ≤ 10%\n\nInclusion criteria for healthy subjects:\n\n* Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)\n\nInclusion criteria for all subjects:\n\n* Subjects with (eGFR ≥ 60 and ≤ 160 mL\u002Fmin\u002F1.73m² and urinary albumin excretion \\\u003C 300 mg\u002Fg creatinine)\n* Body Mass Index (BMI) of 18 to 38 kg\u002Fm²\n* Men and women, ages 18 to 65 years, inclusive\n\nExclusion criteria for all subjects:\n\n* Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus\n* Subjects with T2DM with fasting plasma glucose \\> 200 mg\u002FdL, healthy subjects with fasting plasma glucose \\> 105 mg\u002FdL\n* Subjects with T2DM with HbA1C \\> 10.0%, healthy subjects with HbA1C \\> 6.8%",true,"ALL","18 Years","65 Years",{"count":57,"type":58},24,"ACTUAL","INTERVENTIONAL",[61],"PHASE1","It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.",[64],"Type 2 Diabetes Mellitus","COMPLETED","2016-11-16",{"date":68,"type":69},"2016-11-17","ESTIMATED",{"date":71,"type":11},"2010-08",{"date":73,"type":58},"2010-12",{"name":5,"class":6},1]