[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586257":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":45,"locations":52,"responsibleParty":84,"collaborators":19,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":19,"enrollmentInfo":96,"targetDuration":19,"studyType":99,"phases":100,"briefSummary":103,"conditions":104,"keywords":19,"overallStatus":106,"whyStopped":19,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide","EXPERIMENTAL","Patients will be up-titrated as tolerated starting at 3 mg oral semaglutide once daily for 4 weeks, followed by 7 mg oral semaglutide once daily for 4 weeks and then 14 mg oral semaglutide once daily for 16 weeks. Semaglutide can be down-titrated to previously tolerated dose if the current dose is not tolerated by the participant.",[13,14,15],"Drug: Semaglutide 3 MG [Rybelsus]","Drug: Semaglutide 7 MG [Rybelsus]","Drug: Semaglutide 14 MG [Rybelsus]",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo","PLACEBO_COMPARATOR",null,[21],"Drug: Placebo Oral Tablet",[23,28,32,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":19},"DRUG","Semaglutide 3 MG [Rybelsus]","Semaglutide 3mg for 4 weeks.",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":19},"Semaglutide 7 MG [Rybelsus]","Semaglutide 7mg for 4 weeks.",[9],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":19},"Semaglutide 14 MG [Rybelsus]","Semaglutide 14mg for 16 weeks.",[9],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":19},"Placebo Oral Tablet","Placebo tablet",[17],[41],{"name":42,"affiliation":43,"role":44},"Sunita Singh, MD MSc FRCPC","University Health Network, Toronto General Hospital","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Vesta Lai","CONTACT","416-340-4800","8508","vesta.lai@uhn.ca",[53,71],{"facility":54,"status":19,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"St. Paul's Hospital","Vancouver","British Columbia","V6Z 1Y6","Canada","CA",{"type":61,"coordinates":62},"Point",[63,64],-123.11934,49.24966,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":69,"phoneExt":19,"email":70},"Vikas S Srinivasan, MD FRCPC","604-806-8970","vsrinivasansridhar@providencehealth.bc.ca",{"facility":72,"status":19,"city":73,"state":74,"zip":75,"country":58,"countryCode":59,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Toronto General Hospital","Toronto","Ontario","M5G 2N2",{"type":61,"coordinates":77},[78,79],-79.39864,43.70643,{"lat":79,"lon":78},[82,83],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},{"name":42,"role":44,"phone":19,"phoneExt":19,"email":19},{"type":44,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Sunita Singh, MD, MSc, FRCPC","Principal Investigator","100586257","phase-2-semaglutide-for-the-prevention-of-post-transplant-diabetes-mellitus-100586257",false,"NCT06913023","Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus","SPOT-DM","Inclusion Criteria:\n\n1. Signed and dated written informed consent.\n2. Adult (≥18 years) recipients of a living or deceased donor kidney transplant\n3. Between 4- and 12-weeks post kidney transplant\n4. Stable kidney function defined as an eGFR \\> 30 ml\u002Fmin\u002F1.73m2 (CKD-EPI)\n5. At risk for PTDM at the time of transplant based on the following criteria:\n\n   1. BMI ≥ 25 kg\u002Fm2, or\n   2. Fasting plasma glucose 6.1-6.9 mmol\u002FL (impaired fasting glucose), or\n   3. 2hr OGTT plasma glucose 7.8-11.0 (impaired glucose tolerance), or\n   4. HbA1C 5.5-6.4% (at risk for DM or prediabetes).\n\nExclusion Criteria:\n\n1. Established diagnosis of type 1 or type 2 DM as per Diabetes Canada (including the need for glucose-lowering therapy for hyperglycemia at the time of screening)\n2. Kidney-Pancreas transplant recipient\n3. Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening\n4. History of pancreatitis\n5. Personal or family history of medullary thyroid cancer or MEN2B\n6. Women who are pregnant, nursing or plan on becoming pregnant whilst in the trial\n7. Use of GLP1RA in the 30 days prior to screening\n8. Contraindication to MRI (applicable only to those undergoing the optional MRI assessments)\n9. With known or suspected hypersensitivity to semaglutide or related products\n10. Patient not able to understand and comply with study requirements, based on Investigator's judgment.\n11. Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcom\n12. History of glucose-galactose malabsorption syndrome","ALL","18 Years",{"count":97,"type":98},74,"ESTIMATED","INTERVENTIONAL",[101,102],"PHASE2","PHASE3","The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of placebo and semaglutide therapy in 74 KTR at risk of post-transplant diabetes mellitus (PTDM).",[105],"Kidney Transplant Recipient","NOT_YET_RECRUITING","2025-04-02",{"date":109,"type":110},"2025-04-06","ACTUAL",{"date":112,"type":98},"2026-01-05",{"date":114,"type":98},"2027-11-30",{"name":5,"class":6},2]