[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100425814":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":41,"locations":41,"responsibleParty":49,"collaborators":41,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":41,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":41,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":41,"overallStatus":71,"whyStopped":72,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":79,"leadSponsor":80,"locationsCount":41},{"fullName":5,"class":6},"Zealand Pharma","INDUSTRY",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1","EXPERIMENTAL","Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose",[13,14],"Drug: Dasiglucagon","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence 2","Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Sequence 3","Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Sequence 4","Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Sequence 5","Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Sequence 6","Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose",[13,14],[36,42,45],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Dasiglucagon","dasiglucagon SC, low dose",[9,16,20,24,28,32],null,{"type":37,"name":38,"description":43,"armGroupLabels":44,"otherNames":41},"dasiglucagon SC, high dose",[9,16,20,24,28,32],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":41},"Placebo","placebo for dasiglucagon",[9,16,20,24,28,32],{"type":50,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100425814","phase-2-efficacy-and-safety-of-dasiglucagon-for-treatment-of-post-bariatric-hypoglycemia-in-roux-en-y-gastric-bypass-rygb-operated-adults-100425814",false,"NCT04824872","Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults","A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults","Inclusion Criteria:\n\n* Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening\n* Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates.\n* Body mass index (BMI) ≤ 40 kg\u002Fm2\n* Fasting plasma glucose between 72-106 mg\u002FdL (4.0-6.0 mmol\u002Fl)\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients\n* History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.\n* Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 or end-stage renal disease at screening\n* Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN)\n* Active malignancy, except for basal or squamous cell skin cancers\n* History of a cerebrovascular accident within 6 months prior to screening\n* History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.\n* Congestive heart failure, New York Heart Association Class III or IV\n* Concurrent administration of β-blocker therapy\n* Clinically significant ECG abnormalities at screening","ALL","18 Years","65 Years",{"count":62,"type":63},0,"ACTUAL","INTERVENTIONAL",[66],"PHASE2","The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects",[69,70],"Hypoglycemia","Glucose Metabolism Disorders","WITHDRAWN","Never started","2023-02-16",{"date":75,"type":63},"2023-02-21",{"date":77,"type":78},"2023-02","ESTIMATED",{"date":77,"type":78},{"name":5,"class":6}]