Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 9:45 AM
Study NCT ID:
NCT06972732
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes
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': 'D008687', 'term': 'Metformin'}, {'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 204}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c (%) change at 24 weeks compared to the baseline (Visit 2)', 'timeFrame': 'From baseline to end of treatment at 24 weeks', 'description': 'The mean change of HbA1c at 24 weeks compared to the baseline (Visit 2) is evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, active-controlled, parallel, multicenter, phase IV clinical study evaluating the efficacy and safety of switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has voluntarily agreed to participate in this clinical trial.\n* Adults over 19 years of age\n* Diagnosed with type 2 diabetes\n\nExclusion Criteria:\n\n* Has severe renal and liver disorders\n* Has type 1 diabetes\n* Those who are participating or have participated in other clinical trials and administered their investigational products within 8 weeks before the screening date for this study\n* Those who are deemed ineligible to participate in the study by the investigator'}, 'identificationModule': {'nctId': 'NCT06972732', 'acronym': 'TELOS', 'briefTitle': 'A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Randomized, Open-label, Active-controlled, Parallel, Multicenter, Phase IV Clinical Trial to Compare the Efficacy and Safety of Switching Metformin+SGLT2-i+Dipeptidyl Peptidase-4-inhibitor(DPP-4-i) to Metformin+SGLT2-i+TZD in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BR-DPC-CT-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin + Dapagliflozin 10mg/Pioglitazone 30mg', 'description': 'One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.', 'interventionNames': ['Drug: Metformin', 'Drug: Dapagliflozin/Pioglitazone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin + Dapagliflozin 10mg/Sitagliptin 100mg', 'description': 'One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.', 'interventionNames': ['Drug: Metformin', 'Drug: Dapagliflozin/Sitagliptin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'The dosage and dose frequency are maintained as they were before the screening.', 'armGroupLabels': ['Metformin + Dapagliflozin 10mg/Pioglitazone 30mg', 'Metformin + Dapagliflozin 10mg/Sitagliptin 100mg']}, {'name': 'Dapagliflozin/Pioglitazone', 'type': 'DRUG', 'description': 'Dapagliflozin 10mg/Pioglitazone 30mg QD', 'armGroupLabels': ['Metformin + Dapagliflozin 10mg/Pioglitazone 30mg']}, {'name': 'Dapagliflozin/Sitagliptin', 'type': 'DRUG', 'description': 'Dapagliflozin 10mg/Sitagliptin 100mg QD', 'armGroupLabels': ['Metformin + Dapagliflozin 10mg/Sitagliptin 100mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06591', 'city': 'Seoul', 'state': 'Seocho District', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Oh', 'role': 'CONTACT', 'email': 'syoh@boryung.co.kr', 'phone': '+82 2-708-8000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}