Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-25 @ 2:20 PM
Study NCT ID:
NCT04326166
Status:
UNKNOWN
Last Update Posted:
2021-02-17
First Post:
2020-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C557982', 'term': '4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1971}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'at 12 weeks', 'description': 'To assess change from baseline in HbA1c'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'at 24 weeks', 'description': 'To assess change from baseline in HbA1c'}, {'measure': 'The percentage of patients with HbA1c <7.0% and <6.5%', 'timeFrame': 'at 12 and 24 weeks', 'description': 'To assess the percentage of patients with HbA1c \\<7.0% and \\<6.5%'}, {'measure': 'Change in FPG', 'timeFrame': 'at 12 and 24 weeks', 'description': 'To assess change from baseline in fasting plasma glucose (FPG)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 DM patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject is aged ≥19 years\n2. The subject has type 2 diabetes mellitus\n\nExclusion Criteria:\n\n1\\. The subject has a contraindication'}, 'identificationModule': {'nctId': 'NCT04326166', 'briefTitle': 'Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'Multi-center, Open, Non-intervention and Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab. in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DA1229_DM_OS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients who receive Double therapy or Insulin', 'interventionNames': ['Drug: Evogliptin']}, {'label': 'Group B', 'description': 'Patients who receive DPP-4 inhibitor', 'interventionNames': ['Drug: Evogliptin']}, {'label': 'Group C', 'description': 'Drug-naïve patients', 'interventionNames': ['Drug: Metformin and Evogliptin']}], 'interventions': [{'name': 'Evogliptin', 'type': 'DRUG', 'otherNames': ['Suganon', 'Sugamet XR'], 'description': 'Evogliptin', 'armGroupLabels': ['Group A']}, {'name': 'Evogliptin', 'type': 'DRUG', 'otherNames': ['Suganon', 'Sugamet XR'], 'description': 'Evogliptin', 'armGroupLabels': ['Group B']}, {'name': 'Metformin and Evogliptin', 'type': 'DRUG', 'otherNames': ['Suganon', 'Sugamet XR'], 'description': 'Metformin and Evogliptin', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01757', 'city': 'Seoul', 'state': 'Nowon-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jongchul Won, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'drwonjc@gmail.com', 'phone': '+82-2-950-8860'}], 'facility': 'Sanggye paik pospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jongchul Won, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'dronjc@gmail.com', 'phone': '+82-2-950-8860'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}