Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:15 AM
Study NCT ID:
NCT07365358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'C057619', 'term': 'glimepiride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects who meet 3 conditions at the same time', 'timeFrame': 'Baseline and Week 24', 'description': '1. No hypoglycemic events(\\<70mg/dL) for 24 weeks\n2. No weight change at 24 week\n3. HbA1c \\<7.0% at 24 week'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects who meet 3 conditions at the same time', 'timeFrame': 'Baseline and Week 12', 'description': '1. No hypoglycemic events(\\<70mg/dL) for 12 weeks\n2. No weight change at 12 week\n3. HbA1c \\<7.0% at 12 week'}, {'measure': 'Change from baseline in HbA1c and FPG', 'timeFrame': 'Baseline and Week 24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabete Type 2', 'Empagliflozin'], 'conditions': ['Diabete Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients', 'detailedDescription': 'This study is a Multi-center, Randomized, Open-label, Active comparator-controlled, Phase 4 Clinical Trial to evaluate the efficacy and safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 19 years old\n* Type 2 diabetes mellitus\n* Patient who has been taking oral hypoglycemic agents for over 8 weeks\n* Agreement with written informed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus or secondary diabetes mellitus\n* Patients with complications of severe diabetes such as proliferative diabetic retinopathy\n* Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n* Patients with abnormal laboratory test results according to the protocol\n* Continuous or non-continuous treatment with insulin for over 7 days within 12 weeks prior to screening\n* History of treatment with corticosteroids within 4 weeks prior to screening'}, 'identificationModule': {'nctId': 'NCT07365358', 'acronym': 'EMPAGO', 'briefTitle': 'Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Metformin and Sitagliptin', 'orgStudyIdInfo': {'id': 'B91_02DM2502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expermental group 1', 'description': 'Empamax® 10mg', 'interventionNames': ['Drug: empagliflozin 10mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Expermental group 2', 'description': 'Amaryl® 1mg', 'interventionNames': ['Drug: Glimepiride 1mg']}], 'interventions': [{'name': 'empagliflozin 10mg', 'type': 'DRUG', 'otherNames': ['Empamax 10mg'], 'description': 'once a day for 24 weeks', 'armGroupLabels': ['Expermental group 1']}, {'name': 'Glimepiride 1mg', 'type': 'DRUG', 'otherNames': ['Amaryl 1mg'], 'description': 'once a day for 24 weeks', 'armGroupLabels': ['Expermental group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'In-Kyung Jeong, MD, PhD', 'role': 'CONTACT', 'email': 'jik1016@naver.com', 'phone': '+82-2-440-6126'}], 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'In-Kyung Jeong, MD, PhD', 'role': 'CONTACT', 'email': 'jik1016@naver.com', 'phone': '+82-2-440-6126'}], 'overallOfficials': [{'name': 'In-Kyung Jeong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Hospital at Gangdong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}