[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522395":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":44,"locations":54,"responsibleParty":83,"collaborators":85,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":21,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":21,"overallStatus":57,"whyStopped":21,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Steno Diabetes Center Copenhagen","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Multifactorial intervention group","ACTIVE_COMPARATOR","The multifactorial intervention will be determined by the risk profile and risk markers of each individual and the participants will be allocated to Semaglutide, sotagliflozin or finerenone. The intervention will also comprise more ambitious treatment targets for blood pressure and lipid levels. In addition, all participants will take aspirin 75 mg OD.",[13,14,15,16],"Drug: Aspirin tablet","Drug: Semaglutide","Drug: Sotagliflozin","Drug: Finerenone",{"label":18,"type":19,"description":20,"interventionNames":21},"Standard intervention group","NO_INTERVENTION","During the whole study period the standard intervention shall be done according to current Danish and international (ADA\u002FEASD) guidelines. This will address similar risk factors as in the intensive group, but to a less ambitious treatment target for blood pressure and lipid lowering and will not include the use of SGTL2i, finerenone or GLP-1RA, unless these drug classes become recommended in future versions of guidelines.",null,[23,28,32,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":21},"DRUG","Aspirin tablet","Antiplatelet treatment: with aspirin 75mg OD is mandatory except for concomitant anticoagulant therapy or allergy. In case of allergy clopidogrel will be used.",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":21},"Semaglutide","GLP-1RA treatment: With semaglutide once weekly individually stepped highest tolerable dose according to standard guidelines aiming at 1 mg\u002Fweek for persons with HbA1c \\>53 mmol\u002Fmol or BMI\\>25 kg\u002Fm2 and\u002For ischemic heart disease and\u002For stroke. For safety see below under benefits and risks. Investigators should pay attention to the need for adjustment in insulin dose after initiation of GLP-1RA treatment.",[9],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":21},"Sotagliflozin","SGLT2i treatment with sotagliflozin 200 mg once daily for persons with UACR \\>30 mg\u002Fg and eGFR \\\u003C 45 ml\u002Fmin\u002F1.73 m2 and for persons with a diagnosis of HF. For safety see below under benefits and risks. The limit of eGFR (\\\u003C45ml\u002Fmin) for initiation of SGLT2i treatment is set to reduce risk of ketoacidosis. SGLT2i treatment should not be offered to participants on insulin pump therapy, to reduce risk of ketoacidosis. Investigators should pay attention to the need for adjustment in insulin dose after initiation of SGLT2i treatment.",[9],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":21},"Finerenone","Finerenone: 10 mg once daily titrated to 20 mg as add-on in persons with persistent albuminuria (\\>30 mg\u002Fg) despite RAS blockade.",[9],[41],{"name":42,"affiliation":5,"role":43},"Peter Rossing, MD, DMSc, Proffessor","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":21,"email":49},"Frederik Persson, MD, DMSc","CONTACT","+4521623779","frederik.persson@regionh.dk",{"name":51,"role":47,"phone":52,"phoneExt":21,"email":53},"Elisabeth Stougaard, MD","+4522436292","elisabeth.buur.stougaard@regionh.dk",[55,72],{"facility":56,"status":57,"city":58,"state":21,"zip":21,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Rigshospitalet","RECRUITING","Copenhagen","Denmark","DK",{"type":62,"coordinates":63},"Point",[64,65],12.56553,55.67594,{"lat":65,"lon":64},[68],{"name":69,"role":47,"phone":70,"phoneExt":21,"email":71},"Anne Sophie Mathiesen","N7A","Anne.Sophie.Mathiesen@regionh.dk",{"facility":5,"status":57,"city":73,"state":21,"zip":74,"country":59,"countryCode":60,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Herlev","2730",{"type":62,"coordinates":76},[77,78],12.43998,55.72366,{"lat":78,"lon":77},[81],{"name":82,"role":47,"phone":21,"phoneExt":21,"email":53},"Elisabeth Stougaard, MD, PhD",{"type":84,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[86,88,90,92,94,96,98,100,102,104,106,108,110,112,114,116],{"name":87,"class":6},"Aarhus University Hospital",{"name":89,"class":6},"Steno Diabetes Center Nordjylland",{"name":91,"class":6},"Steno Diabetes Center Odense",{"name":93,"class":6},"Slagelse Hospital",{"name":95,"class":6},"Nykøbing Falster County Hospital",{"name":97,"class":6},"Zealand University Hospital",{"name":99,"class":6},"Hillerod Hospital, Denmark",{"name":101,"class":6},"Rigshospitalet, Denmark",{"name":103,"class":6},"Hvidovre University Hospital",{"name":105,"class":6},"Regionshospitalet Viborg, Skive",{"name":107,"class":6},"Randers Regional Hospital",{"name":109,"class":6},"Herning Hospital",{"name":111,"class":6},"Esbjerg Hospital - University Hospital of Southern Denmark",{"name":113,"class":6},"Regionshospitalet Silkeborg",{"name":115,"class":6},"Bispebjerg Hospital",{"name":117,"class":6},"Regionshospitalet Horsens","100522395","phase-3-multifactorial-intervention-to-reduce-cardiovascular-disease-in-type-1-diabetes-100522395",false,"NCT06082063","Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes","Steno1","Inclusion Criteria:\n\n1. Given written informed consent\n2. Male or female patients ≥40 years old with type 1 diabetes (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies ( in accordance with local guidelines)) during \\>10 years.\n3. Presence of chronic kidney disease (UACR \\>30 mg\u002Fg or eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI\\>35 kg\u002Fm2) OR 10-year CVD risk \\>10% according to Steno Type 1 Risk Engine.\n4. Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. Fertile participants will be pregnancy tested every six months with urine HCG.\n5. Ability to communicate with the investigator and understand informed consent.\n\nExclusion Criteria:\n\n1. Type 2 diabetes, MODY, secondary diabetes.\n2. History of pancreatitis.\n3. Body mass index \\\u003C 18.5 kg\u002Fm2\n4. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.\n5. Known or suspected abuse of alcohol or recreational drugs.\n6. Participant in another intervention study.\n7. CKD stage 5.","ALL","40 Years","90 Years",{"count":129,"type":130},2000,"ESTIMATED","INTERVENTIONAL",[133],"PHASE3","A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.",[136,137,138,139],"Cardiovascular Diseases","Heart Failure","Type 1 Diabetes","Kidney Failure","2025-01-08",{"date":142,"type":143},"2025-01-10","ACTUAL",{"date":145,"type":143},"2024-07-01",{"date":147,"type":130},"2029-07-01",{"name":5,"class":6},2]