[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622108":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":11,"studyPopulation":11,"armGroups":36,"interventions":48,"overallOfficials":11,"centralContacts":56,"locations":62,"responsibleParty":81,"collaborators":11,"id":83,"slug":11,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":11,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":11,"enrollmentInfo":91,"targetDuration":11,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":11,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Hanmi Pharmaceutical Company Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change in HbA1c at 36 weeks compared to baseline",null,"baseline, 36 weeks",[14,17,20,22,25],{"measure":15,"description":11,"timeFrame":16},"Change from baseline in HbA1c at Week 24","baseline, 24 weeks",{"measure":18,"description":11,"timeFrame":19},"Proportion of subjects achieving HbA1c \u003C7.0% at Weeks 24 and 36","24, 36 weeks",{"measure":21,"description":11,"timeFrame":19},"Proportion of subjects achieving HbA1c \u003C6.5% at Weeks 24 and 36",{"measure":23,"description":11,"timeFrame":24},"Change from baseline in FPG at Weeks 24 and 36","baseline, 24, 36 weeks",{"measure":26,"description":11,"timeFrame":19},"Proportion of subjects receiving rescue medication at Weeks 24 and 36",{"allocation":28,"interventionModel":29,"interventionModelDescription":11,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":11,"whoMasked":33},"DOUBLE",[34,35],"PARTICIPANT","INVESTIGATOR",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"HM11260C","EXPERIMENTAL","Weekly administration by subcutaneous injection",[42],"Drug: HM11260C",{"label":44,"type":45,"description":40,"interventionNames":46},"Placebo","PLACEBO_COMPARATOR",[47],"Drug: Placebo",[49,53],{"type":50,"name":38,"description":51,"armGroupLabels":52,"otherNames":11},"DRUG","Test drug",[38],{"type":50,"name":44,"description":54,"armGroupLabels":55,"otherNames":11},"Placebo drug",[44],[57],{"name":58,"role":59,"phone":60,"phoneExt":11,"email":61},"Jee Won Shon","CONTACT","82-2-410-9037","jeewon.shon@hanmi.co.kr",[63],{"facility":64,"status":65,"city":66,"state":11,"zip":11,"country":67,"countryCode":11,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"The Catholic University of Korea Bucheon St. Mary's Hospital","RECRUITING","Gyeonggi-do","South Korea",{"type":69,"coordinates":70},"Point",[71,72],126.76917,37.58944,{"lat":72,"lon":71},[75,78],{"name":76,"role":59,"phone":11,"phoneExt":11,"email":77},"Sung Rae Kim","dream4hope@naver.com",{"name":79,"role":80,"phone":11,"phoneExt":11,"email":11},"Sung Rae Kim, PhD","PRINCIPAL_INVESTIGATOR",{"type":82,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"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":92,"type":93},118,"ESTIMATED","INTERVENTIONAL",[96],"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",[99],"Type 2 Diabetes","2026-05-10",{"date":102,"type":103},"2026-05-13","ACTUAL",{"date":105,"type":103},"2026-04-13",{"date":107,"type":93},"2028-01",{"name":5,"class":6},1]