[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650453":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":42,"centralContacts":46,"locations":52,"responsibleParty":68,"collaborators":41,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":41,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":41,"enrollmentInfo":79,"targetDuration":41,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":98,"whyStopped":41,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Xi'an International Medical Center Hospital","OTHER",[8,14,18,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Fixed 70 U\u002FWeek + Day-4 Supplement (Group A)","ACTIVE_COMPARATOR","Insulin icodec is initiated at a fixed dose of 70 units once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured; if it is at or above 6.8 mmol\u002FL, a one-time supplemental dose equal to 50% of the starting dose (35 units) is given that day. For participants who received the supplemental dose, the day 8 dose returns to the starting dose, and a standardized weekly titration algorithm is applied from day 15 through Week 12.",[13],"Drug: Insulin icodec",{"label":15,"type":10,"description":16,"interventionNames":17},"Fixed 70 U\u002FWeek + No Day-4 Supplement (Group B)","Insulin icodec is initiated at a fixed dose of 70 units once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured for recording only; no supplemental dose is given. A standardized weekly titration algorithm is applied from day 8 through Week 12.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"FBG-Based Dose (FBG×7) + Day-4 Supplement (Group A)","EXPERIMENTAL","Insulin icodec is initiated at a dose calculated as fasting blood glucose (mmol\u002FL) multiplied by 7, given once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured; if it is at or above 6.8 mmol\u002FL, a one-time supplemental dose equal to 50% of the starting dose is given that day. For participants who received the supplemental dose, the day 8 dose returns to the starting dose, and a standardized weekly titration algorithm is applied from day 15 through Week 12.",[13],{"label":24,"type":20,"description":25,"interventionNames":26},"FBG-Based Dose (FBG×7) + No Day-4 Supplement (Group B)","Insulin icodec is initiated at a dose calculated as fasting blood glucose (mmol\u002FL) multiplied by 7, given once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured for recording only; no supplemental dose is given. A standardized weekly titration algorithm is applied from day 8 through Week 12.",[13],{"label":28,"type":20,"description":29,"interventionNames":30},"Weight-Based Dose (BW×0.15×7) + Day-4 Supplement (Group A)","Insulin icodec is initiated at a dose calculated as body weight (kg) multiplied by 0.15 and then by 7, given once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured; if it is at or above 6.8 mmol\u002FL, a one-time supplemental dose equal to 50% of the starting dose is given that day. For participants who received the supplemental dose, the day 8 dose returns to the starting dose, and a standardized weekly titration algorithm is applied from day 15 through Week 12.",[13],{"label":32,"type":20,"description":33,"interventionNames":34},"Weight-Based Dose (BW×0.15×7) + No Day-4 Supplement (Group B)","Insulin icodec is initiated at a dose calculated as body weight (kg) multiplied by 0.15 and then by 7, given once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured for recording only; no supplemental dose is given. A standardized weekly titration algorithm is applied from day 8 through Week 12.",[13],[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Insulin icodec","Once-weekly subcutaneous insulin icodec, injected on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. The starting dose is determined by the assigned initiation strategy: a fixed 70 units per week; fasting blood glucose (mmol\u002FL) multiplied by 7; or body weight (kg) multiplied by 0.15 and then by 7. On day 4, participants in Group A with fasting blood glucose at or above 6.8 mmol\u002FL receive a one-time supplemental dose equal to 50% of the starting dose, while Group B receives no supplemental dose. A standardized weekly titration algorithm is applied through Week 12.",[19,24,9,15,28,32],null,[43],{"name":44,"affiliation":5,"role":45},"Qiuhe Ji","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":41,"email":51},"Tao Liu","CONTACT","86-29-68301145","neifenmi@163.com",[53],{"facility":5,"status":41,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Xi'an","Shaanxi","710100","China","CN",{"type":60,"coordinates":61},"Point",[62,63],108.92861,34.25833,{"lat":63,"lon":62},[66,67],{"name":48,"role":49,"phone":50,"phoneExt":41,"email":51},{"name":48,"role":45,"phone":41,"phoneExt":41,"email":41},{"type":69,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100650453","phase-4-insulin-icodec-initiation-strategies-and-day-4-supplemental-dosing-in-type-2-diabetes-100650453",false,"NCT07747402","Insulin Icodec Initiation Strategies and Day-4 Supplemental Dosing in Type 2 Diabetes","Effects of Different Insulin Icodec Initiation Strategies and a Day-4 Supplemental Dosing Decision on Early Fasting Blood Glucose Target Attainment in Type 2 Diabetes: A Multicenter, Randomized, Open-Label, 3x2 Factorial Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of type 2 diabetes mellitus for at least 180 days\n* No insulin treatment of any kind within the past 3 months\n* Currently treated with at least one non-insulin glucose-lowering agent (oral agent or GLP-1 receptor agonist) with inadequate glycemic control, and a clinical indication to start basal insulin\n* HbA1c of 7.0% to 11.0% at screening\n* Body mass index of 35.0 kg\u002Fm2 or lower\n* Able and willing to wear a continuous glucose monitor per protocol, to undergo day-4 fasting blood glucose assessment, and to attend all scheduled visits\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes, specific types of diabetes, or recent acute complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state\n* Level 2 or level 3 hypoglycemia within the past 3 months, or hypoglycemia unawareness\n* Current use, or use within the past 3 months, of systemic glucocorticoids (excluding inhaled or topical preparations) or other agents that markedly affect blood glucose\n* Moderate to severe renal impairment (eGFR below 45 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI 2021 creatinine equation) or need for dialysis\n* Active liver disease, abnormal liver function (ALT or AST above 3 times the upper limit of normal), or decompensated cirrhosis\n* Marked edema, large-volume ascites, amputation, or other conditions that may impair accurate body weight measurement or distort weight-based dosing\n* Known allergy to insulin icodec or its excipients\n* Extensive skin lesions, allergy to continuous glucose monitor adhesive, or anticipated frequent magnetic resonance imaging that may interfere with monitor wear or interpretation\n* Active malignancy\n* Acute cardiovascular or cerebrovascular event (such as myocardial infarction, stroke, or unstable angina) within the past 6 months, or other major illness with short expected survival or poor compliance\n* Pregnancy or lactation, or women of childbearing potential with pregnancy plans\n* Participation in another drug or device clinical trial within the past 3 months\n* Other conditions judged by the investigator to be unsuitable for enrollment or likely to affect participant safety or data reliability","ALL","18 Years",{"count":80,"type":81},462,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","The goal of this clinical trial is to find the best way to start once-weekly insulin icodec in adults with type 2 diabetes who have not used insulin in the past 3 months, so that their fasting blood glucose reaches the target range within the first week. The main questions it aims to answer are:\n\n* Which of three starting-dose methods brings the most people to their fasting blood glucose target by the end of the first week?\n* On day 4 after starting, if fasting blood glucose is still high, does giving one extra half-dose of insulin help more people reach target safely?\n\nParticipants will be randomly placed into one of three starting-dose groups: a fixed weekly dose, a dose based on their fasting blood glucose, or a dose based on their body weight. Within each group, participants will also be randomly assigned either to receive an extra insulin dose on day 4 if their fasting blood glucose is at or above a set level, or to receive no extra dose.\n\nParticipants will:\n\n* Start once-weekly insulin icodec and continue their current non-insulin diabetes medicines\n* Check their fasting blood glucose, including on day 4 after starting\n* Wear a blinded continuous glucose monitor during the first 2 weeks and the last 2 weeks\n* Attend weekly visits for dose adjustment and safety checks over 12 weeks, followed by a 5-week safety follow-up",[87],"Type 2 Diabetes",[38,89,90,91,92,93,94,95,96,97],"Once-weekly insulin","Basal insulin","Insulin initiation","Fasting blood glucose","Glycemic target attainment","Supplemental dosing","Factorial trial","Continuous glucose monitoring","Diabetes management","NOT_YET_RECRUITING","2026-07-30",{"date":101,"type":102},"2026-08-05","ACTUAL",{"date":104,"type":81},"2027-01",{"date":106,"type":81},"2028-03",{"name":5,"class":6},1]