[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100123255":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":45,"centralContacts":11,"locations":49,"responsibleParty":69,"collaborators":11,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":11,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":91,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"001","EXPERIMENTAL",null,[13],"Drug: JNJ-38431055 Dose 1",{"label":15,"type":10,"description":11,"interventionNames":16},"002",[17],"Drug: JNJ-38431055 Dose 2",{"label":19,"type":20,"description":11,"interventionNames":21},"003","PLACEBO_COMPARATOR",[22],"Drug: Placebo",{"label":24,"type":25,"description":11,"interventionNames":26},"004","ACTIVE_COMPARATOR",[27],"Drug: Sitagliptin 100 mg",[29,34,38,42],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"DRUG","JNJ-38431055 Dose 1","Liquid suspension\u002Fsolution of JNJ-38431055 administered as a single dose",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"Sitagliptin 100 mg","Capsule containing 100 mg of sitagliptin administered as a single dose.",[24],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"Placebo","Placebo suspension\u002Fsolution and Placebo capsule administered as single doses",[19],{"type":30,"name":43,"description":32,"armGroupLabels":44,"otherNames":11},"JNJ-38431055 Dose 2",[15],[46],{"name":47,"affiliation":5,"role":48},"Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial","STUDY_DIRECTOR",[50,61],{"facility":11,"status":11,"city":51,"state":52,"zip":11,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":11},"Fort Myers","Florida","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-81.84059,26.62168,{"lat":59,"lon":58},{"facility":11,"status":11,"city":62,"state":63,"zip":11,"country":53,"countryCode":54,"cosmosGeoPoint":64,"geoPoint":68,"contacts":11},"San Antonio","Texas",{"type":56,"coordinates":65},[66,67],-98.49363,29.42412,{"lat":67,"lon":66},{"type":70,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100123255","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-explores-what-the-body-does-to-the-drug-and-pharmacodynamics-explores-what-a-drug-does-to-the-body-of-jnj-38431055-in-volunteers-with-type-2-diabetes-mellitus-100123255",false,"NCT00871507","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus","SD in Subjects With T2DM","Inclusion Criteria:\n\n* Males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus\n* Medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ECG performed at Screening\n* Body Mass Index (BMI) between 22 and 39.9 kg\u002Fm2, inclusive\n* On a generally stable antihyperglycemic agent regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the Screening Visit, including volunteers who are:(a) Not currently on antihyperglycemic therapy and have an HbA1c =7.0% and =10.0%, or (b) On a single oral antihyperglycemic agent \\[metformin, a sulfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a DPP-4 inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)\\] and have an HbA1c \\>=6.5% and \\\u003C=9.5%, or (c) On low-dose dual oral agent therapy (i.e., \\\u003C50% maximum labeled doses of both agents) and have an HbA1c \\>=6.5% and \\\u003C=9.5%\n* On Day -1, FPG concentrations between 120 mg\u002FdL and 260 mg\u002FdL, inclusive.\n\nExclusion Criteria:\n\n* Taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other GLP-1 analogues), or taking a thiazolidinedione (i.e., a PPARg agonist) within 3 months of Day -1\n* History of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness\n* History of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis\n* Positive test for alcohol and\u002For drugs of abuse\n* Psychological and\u002For emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements\n* Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.","ALL","25 Years","60 Years",{"count":82,"type":83},25,"ACTUAL","INTERVENTIONAL",[86],"PHASE1","This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of JNJ-38431055 in volunteers with type 2 diabetes mellitus.",[89],"Diabetes Mellitus, Type 2",[89],"COMPLETED","2014-05-21",{"date":94,"type":95},"2014-05-22","ESTIMATED",{"date":97,"type":11},"2009-04",{"date":99,"type":83},"2009-07",{"name":5,"class":6},2]