[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622108":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":53,"collaborators":24,"id":55,"slug":24,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":24,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Hanmi Pharmaceutical Company Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HM11260C","EXPERIMENTAL","Weekly administration by subcutaneous injection",[13],"Drug: HM11260C",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Test drug",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Placebo drug",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Jee Won Shon","CONTACT","82-2-410-9037","jeewon.shon@hanmi.co.kr",[35],{"facility":36,"status":37,"city":38,"state":24,"zip":24,"country":39,"countryCode":24,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The Catholic University of Korea Bucheon St. Mary's Hospital","RECRUITING","Gyeonggi-do","South Korea",{"type":41,"coordinates":42},"Point",[43,44],126.76917,37.58944,{"lat":44,"lon":43},[47,50],{"name":48,"role":31,"phone":24,"phoneExt":24,"email":49},"Sung Rae Kim","dream4hope@naver.com",{"name":51,"role":52,"phone":24,"phoneExt":24,"email":24},"Sung Rae Kim, PhD","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100622108",false,"NCT07379333","A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin","A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin","Inclusion Criteria:\n\n* 1\\. Adults aged 19 years or older\n* 2\\. Diagnosed with type 2 diabetes\n* 3\\. HbA1c level 7.0% ≤ HbA1c ≤ 10.0%\n* 4\\. Stable administration of metformin (≥1,000 mg\u002Fday) and dapagliflozin (10 mg\u002Fday) without any change in dosage or formulation for at least 8 weeks prior to Visit 1\n* 5\\. 20 kg\u002Fm2 ≤ BMI ≤ 45 kg\u002Fm2\n* 6\\. Agree to the recommended exercise and diet regimen during this clinical trial\n\nExclusion Criteria:\n\n* 1\\. Patients with a history of allergy or resistance to the investigational drug or background therapy\n* 2\\. Patients diagnosed with a type of diabetes other than type 2 diabetes\n* 3\\. Patients with uncontrolled severe diabetic complications\n* 4\\. Patients with a history of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis.\n* 5\\. Patients with a history of diabetic coma or precoma\n* 6\\. Those with a history of severe hypoglycemia\n* 7\\. Those whose weight change \\> 5 kg\n* 8\\. History of gastrointestinal disease or surgery\n* 9\\. History of bariatric surgery\n* 10\\. History of gallbladder disease\n* 11\\. History of a disease that could affect the interpretation of HbA1c\n* 12\\. History of acute or chronic pancreatitis or pancreatectomy\n* 13\\. History (including family history) of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN2).\n* 14\\. Uncontrolled hypertension\n* 15\\. Severe infections or severe trauma\n* 16\\. Malnutrition, starvation, or debility, as determined by the investigator.\n* 17\\. Pituitary or adrenal insufficiency.\n* 18\\. Tissue hypoxia, such as respiratory failure or shock.\n* 19\\. History of alcoholism or drug abuse\n* 20\\. History of malignant tumors\n* 21\\. Heart failure, Ischemic heart disease, Severe cerebrovascular disease, TIA\n* 22\\. Patients with one of the following clinical laboratory test results : Amylase or Lipase \\> 3 X ULN \u002F FPG \\> 270 mg\u002FdL\n* 23\\. Patients with severe hepatic impairment or one of the following laboratory test results : AST or ALT \\> 3 X ULN \u002F Total bilirubin \\> 1.5 X ULN\n* 24\\. Patients with moderate or severe renal impairment\n* 25\\. History of Diabetic medications or weight-loss medications\n* 26\\. Those who have participated in another clinical trial and received investigational drugs within 30 days\n* 27\\. Pregnant or lactating women, or women of childbearing potential\n* 28\\. Women of childbearing potential and men who do not consent to the use of the following contraceptive methods\n* 29\\. Considered by investigator as not appropriate to participate in the clinical study with other reason.","ALL","19 Years",{"count":64,"type":65},118,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in patients with type 2 diabetes mellitus inadequately controlled with metformin and dapagliflozin",[71],"Type 2 Diabetes","2026-05-10",{"date":74,"type":75},"2026-05-13","ACTUAL",{"date":77,"type":75},"2026-04-13",{"date":79,"type":65},"2028-01",{"name":5,"class":6},1]