Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-30 @ 5:13 PM
Study NCT ID:
NCT06188234
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prescription Patterns and Clinical Efficacy of Tenero Tab/Tenero M SR 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c at 6 months of prescribing Tenero Tablet/Tenero Emextended Release Tablet compared to baseline', 'timeFrame': 'after 6 months of prescription for Tenero Tab/Tenero M SR Tab compared to baseline', 'description': 'Change in HbA1c at 6 months of prescribing Tenero Tablet/Tenero Emextended Release Tablet compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metformin HCI', 'Teneligliptin hydrochloride'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study is to observe the prescription patterns and clinical efficacy of patients prescribed with Tenero Tab/Tenero M SR Tab for diabetes treatment in routine clinical practice.', 'detailedDescription': 'This study is to observe the clinical efficacy by analyzing the prescription patterns in routine clinical practice and changes in HbA1c, FPG, PP2G, etc., of patients prescribed with Tenero Tab/Tenero M SR Tab for diabetes treatment. Additionally, the study intends to assess patient satisfaction based on these observations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients prescribed Tenero Tab/Tenero M SR Tab for diabetes treatment.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults over 19 years of age\n2. Individuals diagnosed with type 2 diabetes.\n3. Individuals who, at the clinical discretion, are prescribed Tenero Tab or Tenero M SR Tab for the purpose of diabetes treatment for the first time.\n4. Individuals who have voluntarily provided written consent to participate in this study.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Individuals who are contraindicated according to the approved indications of Tenero Tab/Tenero M SR Tab.\n3. Other cases where the principal investigator and study personnel deem individuals ineligible for participation in this clinical trial.'}, 'identificationModule': {'nctId': 'NCT06188234', 'briefTitle': 'The Prescription Patterns and Clinical Efficacy of Tenero Tab/Tenero M SR Tab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanlim Pharm. Co., Ltd.'}, 'officialTitle': 'Observational Study on the Prescription Patterns and Clinical Efficacy of Tenero Tab/Tenero M SR Tab in Korean Type 2 Diabetes Mellitus Patients', 'orgStudyIdInfo': {'id': 'HL-TNL/M-401'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cheonan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seokgi Yoon', 'role': 'CONTACT', 'phone': '82-41-592-7201'}], 'facility': 'Cheonan Endo Medical Clinic', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}], 'centralContacts': [{'name': 'Yeonhwa Kim', 'role': 'CONTACT', 'email': 'yh@hanlim.com', 'phone': '82-2-3489-6163'}], 'overallOfficials': [{'name': 'Seokgi Yoon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHEONAN ENDO MEDICAL CLINIC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}