[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519723":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":139,"collaborators":143,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":158,"sex":164,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":33,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":33,"overallStatus":51,"whyStopped":33,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Kantonsspital Baden","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","1000 mg dapansutrile (2 × 500mg tablets) administered twice a day from day 1 through the week 26 visit, inclusive. All tablets will be self-administered by mouth with water, with or without food.",[13],"Drug: Dapansutrile",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","Matching placebo (2 tablets) administered twice a day from day 1 through the Week 26 visit, inclusive. All tablets will be self-administered by mouth with water, with or without food.",[19],"Drug: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dapansutrile","Patients receive investigational product.",[9],[27,28],"3-methanesulfonyl-propionitrile","OLT1177",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","Patients receive placebo.",[15],null,[35],{"name":36,"affiliation":37,"role":38},"Marc Y. Donath, Prof.","Kantonsspital Baden, Switzerland","STUDY_CHAIR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":33,"email":43},"CONTACT","+41 61 265 50 78","marc.donath@umontreal.ca",{"name":45,"role":41,"phone":46,"phoneExt":33,"email":47},"Markus Veit","+41 56 486 25 14","markus.veit@ksb.ch",[49,67,84,95,112,124],{"facility":50,"status":51,"city":52,"state":33,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"CHU de Liege","RECRUITING","Liège","4000","Belgium","BE",{"type":57,"coordinates":58},"Point",[59,60],5.56749,50.63373,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":33,"email":66},"Nathalie Esser, ass. Prof.","+32 4 323 72 37","nathalie.esser@chuliege.be",{"facility":68,"status":51,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Hopital Lariboisiere","Paris","Île-de-France Region","75010","France","FR",{"type":57,"coordinates":75},[76,77],2.3488,48.85341,{"lat":77,"lon":76},[80],{"name":81,"role":41,"phone":82,"phoneExt":33,"email":83},"Jean-Francois Gautier, Prof. Dr. med. Dr. sci. nat.","+33 1 49 95 90 73","jean-francois.gautier@aphp.fr",{"facility":85,"status":51,"city":69,"state":70,"zip":86,"country":72,"countryCode":73,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Hopital Bichat","75018",{"type":57,"coordinates":88},[76,77],{"lat":77,"lon":76},[91],{"name":92,"role":41,"phone":93,"phoneExt":33,"email":94},"Louis Potier, ass. Prof.","+33 1 40 25 82 42","louis.potier@aphp.fr",{"facility":96,"status":51,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Deutsches Zentrum für Diabetesforschung Düsseldorf","Düsseldorf","Nordrhein-Westphalen","40225","Germany","DE",{"type":57,"coordinates":103},[104,105],6.77927,51.22319,{"lat":105,"lon":104},[108],{"name":109,"role":41,"phone":110,"phoneExt":33,"email":111},"Michael Roden, Prof. Dr. med.","+49 211 3382-0","kontakt@ddz.de",{"facility":113,"status":114,"city":115,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":33},"University Hospital Basel","TERMINATED","Basel","4031","Switzerland","CH",{"type":57,"coordinates":120},[121,122],7.57327,47.55839,{"lat":122,"lon":121},{"facility":125,"status":51,"city":126,"state":127,"zip":128,"country":117,"countryCode":118,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Kantonsspital Olten","Olten","Canton of Solothurn","4600",{"type":57,"coordinates":130},[131,132],7.90329,47.34999,{"lat":132,"lon":131},[135],{"name":136,"role":41,"phone":137,"phoneExt":33,"email":138},"Thomas Züger, Prof. Dr. med.","+41 62 311 41 11","thomas.zueger@spital.so.ch",{"type":140,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Marc Donath","Prof. Dr. med.",[144,147,149,152,154],{"name":145,"class":146},"European Union (Horizon Europe Programme)","UNKNOWN",{"name":148,"class":6},"State Secretariat for Education Research and Innovation, Switzerland",{"name":150,"class":151},"Olatec Therapeutics LLC","INDUSTRY",{"name":153,"class":146},"Departement Klinische Forschung Universität Basel",{"name":155,"class":146},"CTU Kantonsspital Baden","100519723","phase-2-dapansutrile-in-diabetes-and-diabetes-related-complications---dapan-dia-100519723",false,"NCT06047262","Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia","A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of the Oral NLRP3 Inhibitor Dapansutrile in Subjects With Type 2 Diabetes Mellitus","Dapan-Dia","Inclusion Criteria:\n\n* Diagnosis of type 2, Diabetes mellitus as defined by the criteria of the American Diabetes Association (ADA) Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (see Appendix 1) and recognized by the World Health Organization (WHO, 2019), for at least 3 months prior to the Baseline Visit\u002FDay 1\n* HbA1c value of ≥ 7.7% to ≤ 11.0% at the Screening Visit.\n* High-sensitivity C-reactive protein (hsCRP) ≥ 1.5 mg\u002FL at the Screening Visit.\n* Body mass index (BMI) ≥25 to ≤ 40 kg\u002Fm2 at the Screening Visit\n* Acceptable overall medical condition to safely participate in the study and complete all study procedures (particularly with regard to cardiovascular, renal, and hepatic conditions), in the opinion of the Investigator\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus\n* HbA1c value of ≤ 7.5% or ≥ 10.5% at the Baseline Visit\u002FDay 1, as determined at point of care (local laboratory)\n* Use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin\u002Finsulin analogues (as bolus or premixed insulin) within 12 weeks prior to the Screening Visit\n* Less than 80% compliance in taking investigational medicinal product by pill count during the Run-In Period, as assessed at the Baseline Visit\u002FDay 1\n* Significant weight loss (\\> 5 kg) in the 12 weeks prior to the Screening Visit\n* Systolic blood pressure (BP) ≥ 160 mmHg, diastolic BP ≥ 100 mmHg, or resting heart rate (HR) ≥ 100 beats\u002Fminute at the Screening Visit\n* Previous myocardial infarction, any cardiac surgery","ALL","18 Years","75 Years",{"count":168,"type":169},300,"ESTIMATED","INTERVENTIONAL",[172],"PHASE2","The aim of the study is to determine whether NLRP3 inhibition with dapansutrile represents a new pharmacological option for diabetes management with potential as an anti-inflammatory agent to also address micro- and macro-vascular risk and complications from diabetes.",[175],"Diabetes Mellitus, Type 2","2026-02-23",{"date":178,"type":179},"2026-02-25","ACTUAL",{"date":181,"type":179},"2024-07-09",{"date":183,"type":169},"2028-07-31",{"name":141,"class":6},6]