[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535051":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":56,"centralContacts":60,"locations":70,"responsibleParty":94,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":64,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":64,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":64,"overallStatus":73,"whyStopped":64,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,15,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Group IC","EXPERIMENTAL","Tirzepatide starting at 2.5mg weekly titrated to 15mg weekly (2.5 month 1, 5mg month 2, 10mg month 3 and 15mg at month 4) with Pioglitazone beginning at 15mg daily and ending at 45mg daily (15mg month 1, 30mg month 2 and 45mg at month 3 onwards).",[13,14],"Drug: Tirzepatide","Drug: Pioglitazone",{"label":16,"type":17,"description":18,"interventionNames":19},"Group II","ACTIVE_COMPARATOR","Metformin starting at 1000mg XR daily and Sitagliptin 100mg daily at week 4, Metformin will be increased to 200mg.",[20,21],"Drug: Sitagliptin","Drug: Metformin HCI XR",{"label":23,"type":17,"description":24,"interventionNames":25},"Group IA","Tirzepatide will be started at 2.5mg and increased to 15mg by month 4. At month 6, Pioglitazone will be added to the Tirzepatide, 15 mg daily.",[13,14],{"label":27,"type":17,"description":28,"interventionNames":29},"Group 1B","Pioglitazone will be started at 15mg and increased to 45 mg by month 3. At month 6, tirzepatide 2.5mg will be started and increased weekly as tolerated.",[13,14],[31,38,44,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Tirzepatide","Tirzepatide:Participants will be initiated on 2.5mg weekly and increase their dose to 5mg at week 4, 10mg at week 8 and 15mg at week 12 as tolerated.",[27,23,9],[37],"Mounjaro",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Pioglitazone","Pioglitazone: Participants will begin therapy at 15mg daily for the first 4 weeks then increase dose to 30mg at week 4 and to 45 mg at week 8, as tolerated.",[27,23,9],[43],"Actos",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Sitagliptin","Sitagliptin: will be administered as a 100mg dose once daily.",[16],[49],"Januvia",{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Metformin HCI XR","Metformin will be administered at a dose of 1000mg for the first 4 weeks and then the dose increased to 2000mg.",[16],[55],"Extended Release Metformin",[57],{"name":58,"affiliation":5,"role":59},"Muhammad Abdul-Ghani, MD","PRINCIPAL_INVESTIGATOR",[61,66],{"name":58,"role":62,"phone":63,"phoneExt":64,"email":65},"CONTACT","210-567-6691",null,"abdulghani@uthscsa.edu",{"name":67,"role":62,"phone":68,"phoneExt":64,"email":69},"Gozde Baskoy, PhD","210-358-7200","baskoy@uthscsa.edu",[71,88],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"University Health System Texas Diabetic Institute","RECRUITING","San Antonio","Texas","78207","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-98.49363,29.42412,{"lat":83,"lon":82},[86],{"name":58,"role":62,"phone":87,"phoneExt":64,"email":65},"210-567-2391",{"facility":89,"status":73,"city":74,"state":75,"zip":90,"country":77,"countryCode":78,"cosmosGeoPoint":91,"geoPoint":93,"contacts":64},"UT Health Science Center","78229",{"type":80,"coordinates":92},[82,83],{"lat":83,"lon":82},{"type":95,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR",[97],{"name":98,"class":99},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100535051","phase-3-comparative-effectiveness-of-two-initial-combination-therapies-in-patients-with-recent-onset-diabetes-100535051",false,"NCT06246799","Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes","Comparative Effectiveness of Two Initial Combination Therapies in Patients With New Onset Diabetes","Inclusion Criteria:\n\n1. Ability of subject to understand and the willingness to sign a written informed consent document.\n2. Males and females; Age 18-75 years\n3. Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients\n4. Drug naïve or receiving metformin monotherapy\n5. HbA1c \\>6.5% (no limit on upper HbA1c value);\n6. Willingness to adhere to the investigational product regimen\n7. Good general health\n8. Stable body weight over the preceding 3 months\n9. Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n1. positive anti-GAD (antibodies to glutamic acid decarboxylase)\n2. pregnancy or plan of becoming pregnant\n3. evidence of proliferative diabetic retinopathy,\n4. plasma creatinine \\>1.4 females or \\>1.5 males;\n5. presence of congestive heart failure (CHF);\n6. history of cancer (\\\u003C5 years);\n7. prior history of pancreatitis,\n8. bladder cancer or family history of thyroid tumors;\n9. presence of hematuria in the urine analysis.","ALL","18 Years","75 Years",{"count":111,"type":112},256,"ESTIMATED","INTERVENTIONAL",[115],"PHASE3","The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.",[118],"Type 2 Diabetes (Adult Onset)","2026-03-09",{"date":121,"type":122},"2026-03-10","ACTUAL",{"date":124,"type":122},"2024-11-07",{"date":126,"type":112},"2029-06-30",{"name":5,"class":6},2]