Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-01 @ 10:55 AM
Study NCT ID:
NCT07379333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c at 36 weeks compared to baseline', 'timeFrame': 'baseline, 36 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in HbA1c at Week 24', 'timeFrame': 'baseline, 24 weeks'}, {'measure': 'Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36', 'timeFrame': '24, 36 weeks'}, {'measure': 'Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36', 'timeFrame': '24, 36 weeks'}, {'measure': 'Change from baseline in FPG at Weeks 24 and 36', 'timeFrame': 'baseline, 24, 36 weeks'}, {'measure': 'Proportion of subjects receiving rescue medication at Weeks 24 and 36', 'timeFrame': '24, 36 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/day) and dapagliflozin (10 mg/day) without any change in dosage or formulation for at least 8 weeks prior to Visit 1\n* 5\\. 20 kg/m2 ≤ BMI ≤ 45 kg/m2\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 / FPG \\> 270 mg/dL\n* 23\\. Patients with severe hepatic impairment or one of the following laboratory test results : AST or ALT \\> 3 X ULN / 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.'}, 'identificationModule': {'nctId': 'NCT07379333', 'briefTitle': 'A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HM-GLOW-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HM11260C', 'description': 'Weekly administration by subcutaneous injection', 'interventionNames': ['Drug: HM11260C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Weekly administration by subcutaneous injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HM11260C', 'type': 'DRUG', 'description': 'Test drug', 'armGroupLabels': ['HM11260C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo drug', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggi-do', 'country': 'South Korea', 'contacts': [{'name': 'Sung Rae Kim', 'role': 'CONTACT', 'email': 'dream4hope@naver.com'}, {'name': 'Sung Rae Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Catholic University of Korea Bucheon St. Mary's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'centralContacts': [{'name': 'Jee Won Shon', 'role': 'CONTACT', 'email': 'jeewon.shon@hanmi.co.kr', 'phone': '82-2-410-9037'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}