[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584855":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":54,"locations":63,"responsibleParty":90,"collaborators":93,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":28,"enrollmentInfo":106,"targetDuration":28,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":66,"whyStopped":28,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide, Ozempic® (at maximum tolerated dose) + Automated Insulin Delivery system","EXPERIMENTAL","Semaglutide is a Glucagon-Like Peptide 1 Receptor Agonist. It stimulates GLP1 in the body, which allows for increased satiety, reduced glucagon levels, delayed gastric emptying, and in some, increased insulin secretion. It is a once per week subcutaneous injection.\n\nParticipants will self-administer the colourless solution subcutaneously in the abdomen, thighs, or upper arms once weekly per the dosing schedule below.\n\nWeeks 1-4 : 0.25 mg (0.19 mL) Weeks 5-8 : 0.50 mg (0.38 mL) Weeks 9-12 : 1.0 mg (0.74 mL) Weeks 13-22 : 1.0 mg (0.74 mL)\n\nTo match the recommendation from the product monograph and to ensure a steady state is reached before initiating the evaluation period, study drugs will be titrated for 12 weeks.",[13,14,15,16],"Drug: Intervention Period 1: Semaglutide + Empagliflozin","Drug: Intervention Period 2: Semaglutide + Empagliflozin Placebo","Drug: Intervention Period 3: Semaglutide Placebo + Empagliflozin","Drug: Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo",{"label":18,"type":19,"description":20,"interventionNames":21},"Placebo + Automated Insulin Delivery system","ACTIVE_COMPARATOR","Participants will self-administer the colourless solution subcutaneously in the abdomen, thighs, or upper arms once weekly per the dosing schedule below.\n\nWeeks 1-4 : 0.19 mL Weeks 5-8 : 0.38 mL Weeks 9-12 : 0.74 mL Weeks 13-22 : 0.74 mL\n\nTo match the recommendation from the product monograph and to ensure a steady state is reached before initiating the evaluation period, study drugs will be titrated for 12 weeks.",[13,14,15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Intervention Period 1: Semaglutide + Empagliflozin","Semaglutide Injection: Subcutaneous injection, titrated over 12 weeks to a stable dose (1 mg), administered weekly.\n\nEmpagliflozin Tablet: Oral tablet (2.5 mg), administered daily.\n\nAutomated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system.",[18,9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Intervention Period 2: Semaglutide + Empagliflozin Placebo","Semaglutide Injection: Subcutaneous injection, titrated over 12 weeks to a stable dose (1 mg), administered weekly.\n\nEmpagliflozin Placebo Tablet: Oral placebo tablet, matched in appearance to empagliflozin (2.5 mg), administered daily.\n\nAutomated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system.",[18,9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Intervention Period 3: Semaglutide Placebo + Empagliflozin","Semaglutide Placebo Injection: Subcutaneous placebo injection (titrated over 12 weeks to a stable 1 mg dose), matched in appearance to semaglutide, administered weekly.\n\nEmpagliflozin Tablet: Oral tablet (2.5 mg), administered daily.\n\nAutomated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system.",[18,9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo","Semaglutide Placebo Injection: Subcutaneous placebo injection (titrated over 12 weeks to a stable 1 mg dose), matched in appearance to semaglutide, administered weekly.\n\nEmpagliflozin Placebo Tablet: Oral placebo tablet (2.5 mg), matched in appearance to empagliflozin, administered daily.\n\nAutomated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system.",[18,9],[42,46,49,51],{"name":43,"affiliation":44,"role":45},"Dr. Michael Tsoukas","Division of Endocrinology and Metabolism - McGill University Health Center","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":44,"role":48},"Dr. Melissa-Rosina Pasqua","STUDY_DIRECTOR",{"name":50,"affiliation":44,"role":48},"Dr. Vanessa Tardio",{"name":52,"affiliation":53,"role":48},"Dr. Ahmad Haidar","Department of Biomedical Engineering - McGill University",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":28,"email":59},"Keddy Moise, BScHS","CONTACT","438-531-6896","keddy.moise@affiliate.mcgill.ca",{"name":52,"role":57,"phone":61,"phoneExt":28,"email":62},"514-398-4491","ahmad.haidar@mcgill.ca",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Research Institute of the McGill University Health Centre","RECRUITING","Montreal","Quebec","H4A 3J1","Canada","CA",{"type":73,"coordinates":74},"Point",[75,76],-73.58781,45.50884,{"lat":76,"lon":75},[79,80,82,84,86,88],{"name":56,"role":57,"phone":58,"phoneExt":28,"email":59},{"name":81,"role":57,"phone":61,"phoneExt":28,"email":62},"Dr. Ahmad Haidar, PhD",{"name":83,"role":45,"phone":28,"phoneExt":28,"email":28},"Dr. Michael Tsoukas, MD, FRCPC",{"name":81,"role":85,"phone":28,"phoneExt":28,"email":28},"SUB_INVESTIGATOR",{"name":87,"role":85,"phone":28,"phoneExt":28,"email":28},"Dr. Melissa-Rosina Pasqua, MD, FRCPC",{"name":89,"role":85,"phone":28,"phoneExt":28,"email":28},"Dr. Vanessa Tardio, MD, FRCPC",{"type":45,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Michael Tsoukas","Assistant Professor of Medicine, Principal Investigator",[94],{"name":95,"class":6},"Diabetes Canada","100584855","phase-3-a-clinical-trial-to-evaluate-the-effects-of-semaglutide-and-empagliflozin-combined-to-automated-insulin-delivery-on-diabetes-control-in-adults-living-with-type-1-diabetes-100584855",false,"NCT06894784","A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes","Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes (SEMPA)","SEMPA","The inclusion criteria at the time of enrollment are:\n\n* Males and females aged 18 or older.\n* Clinical diagnosis of T1D for at least one year.\n* Use of AID system for at least three months.\n* Body Mass Index (BMI) ≥ 23 kg\u002Fm2.\n\nThe exclusion criteria are:\n\n* Use of GLP1-RA within one month of admission.\n* Use of SGLT2i within two weeks of admission.\n* Planned or ongoing pregnancy.\n* Breastfeeding.\n* Severe hypoglycemic episode within three months of admission (defined as an event where blood glucose levels were \\\u003C 4.0 mmol\u002FL, resulting in seizure, loss of consciousness, or the need to present to the emergency department).\n* Diabetic ketoacidosis episode within six months of admission.\n* History of acute pancreatitis, chronic pancreatitis, or gallbladder disease.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe impairment of renal function with an eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 within four months of admission. eGFR will be computed using the CKD-EPI method.\n* Clinically significant diabetic retinopathy or gastroparesis, as per the investigator's judgement.\n* Bariatric surgery within six months of admission.\n* A serious medical or psychiatric illness that would likely interfere with participation in this study, as per the investigator's judgement.\n* Inability or unwillingness to comply with safe diabetes management practices, as per the investigator's judgment.","ALL","18 Years",{"count":107,"type":108},36,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","The goal of this clinical trial is to learn if Empagliflozin and Semaglutide, individually and combined, added to Automated Insulin Delivery (AID) works to improve time-in-range in adults living with Type 1 Diabetes. It will also evaluate the safety of Empagliflozin and Semaglutide in this context.\n\nThe primary hypothesis of this study is :\n\n\\- The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to placebo when added to AID therapy.\n\nThe secondary hypotheses are :\n\n* The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to semaglutide alone when added to AID therapy.\n* The combination of semaglutide and empagliflozin will increase time-in-range compared to empagliflozin alone when added to AID therapy.\n\nIn this study, the research team will compare Empagliflozin and Semaglutide to a placebo (a look-alike substance that contains no drug) to see if they improve time-in-range.\n\nThis study has four groups:\n\nGroup 1: semaglutide injection + empagliflozin tablet. Group 2: semaglutide injection + placebo tablet. Group 3: placebo injection + empagliflozin tablet. Group 4: placebo injection + placebo tablet.\n\nThis is a 2x2 factorial crossover study. This means that all participants will undergo both injection intervention (placebo and semaglutide) arms. Within each injection arm, participants will take both tablets (placebo and empagliflozin). By the end of the study, every participant will have taken part in each study group.",[114],"Diabetes Type 1",[116,117,118,119,120,121,122,123,124],"T1D","Combination Therapy","Automated Insulin Delivery","SGLT2-i","GLP1-RA","Insulin","Artificial Pancreas","GLP-1 receptor agonist","Diabetes Mellitus, Type 1","2025-03-25",{"date":127,"type":128},"2025-03-30","ACTUAL",{"date":130,"type":108},"2025-04",{"date":132,"type":108},"2027-01",{"name":5,"class":6},1]