Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-02 @ 12:43 AM
Study NCT ID:
NCT05194592
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020257', 'term': 'Ventricular Remodeling'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C534891', 'term': 'LC15-0444'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid', 'timeFrame': '6 months', 'description': 'The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up'}, {'measure': 'Change (%) in LV mass index', 'timeFrame': '6 months', 'description': 'The change of LV mass index from baseline to 6 months follow-up'}], 'secondaryOutcomes': [{'measure': 'Change (%) in LV ejection global longitudinal strain', 'timeFrame': '6 months', 'description': 'The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up'}, {'measure': 'Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure', 'timeFrame': '6 months', 'description': 'The change of mean 24hr ambulatory systolic and diastolic blood pressurefrom baseline to 6 months follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes', 'Remodeling, Ventricular']}, 'referencesModule': {'references': [{'pmid': '32943171', 'type': 'BACKGROUND', 'citation': 'Correction. J Am Coll Cardiol. 2020 Sep 22;76(12):1505. doi: 10.1016/j.jacc.2020.08.010. No abstract available.'}, {'pmid': '25271206', 'type': 'BACKGROUND', 'citation': 'Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ; EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015 Mar;38(3):420-8. doi: 10.2337/dc14-1096. Epub 2014 Sep 30.'}, {'pmid': '30132036', 'type': 'BACKGROUND', 'citation': 'Verma S, McMurray JJV. SGLT2 inhibitors and mechanisms of cardiovascular benefit: a state-of-the-art review. Diabetologia. 2018 Oct;61(10):2108-2117. doi: 10.1007/s00125-018-4670-7. Epub 2018 Aug 22.'}, {'pmid': '32358544', 'type': 'BACKGROUND', 'citation': 'Kim SR, Lee SG, Kim SH, Kim JH, Choi E, Cho W, Rim JH, Hwang I, Lee CJ, Lee M, Oh CM, Jeon JY, Gee HY, Kim JH, Lee BW, Kang ES, Cha BS, Lee MS, Yu JW, Cho JW, Kim JS, Lee YH. SGLT2 inhibition modulates NLRP3 inflammasome activity via ketones and insulin in diabetes with cardiovascular disease. Nat Commun. 2020 May 1;11(1):2127. doi: 10.1038/s41467-020-15983-6.'}, {'pmid': '33648515', 'type': 'BACKGROUND', 'citation': 'Gaborit B, Ancel P, Abdullah AE, Maurice F, Abdesselam I, Calen A, Soghomonian A, Houssays M, Varlet I, Eisinger M, Lasbleiz A, Peiretti F, Bornet CE, Lefur Y, Pini L, Rapacchi S, Bernard M, Resseguier N, Darmon P, Kober F, Dutour A. Effect of empagliflozin on ectopic fat stores and myocardial energetics in type 2 diabetes: the EMPACEF study. Cardiovasc Diabetol. 2021 Mar 1;20(1):57. doi: 10.1186/s12933-021-01237-2.'}, {'pmid': '32578850', 'type': 'BACKGROUND', 'citation': 'Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial. Eur Heart J. 2020 Sep 21;41(36):3421-3432. doi: 10.1093/eurheartj/ehaa419.'}]}, 'descriptionModule': {'briefSummary': 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardiovascular and renal protection in patients with type 2 diabetes (T2D); however, the underlying mechanism remains unclear. We hypothesized that SGLT2 inhibitor will improve the ketone metabolism compared to dipeptidyl Peptidase-4 (DPP4) inhibitor. And we will also evaluate the association between ketone metabolism and cardiac remodeling evaluated by echocardiography. We will randomly assign 122 people with T2DM to receive dapagliflozin 10mg or gemigliptin 50mg. The primary endpoint are changes in acetoacetate, total ketone, beta-hydroxybutyric acid, left ventricular (LV) mass index, and LV global longitudinal strain during 6 months follow-up. This study may provide robust evidence of the thrifty substrate hypothesis for cardiovascular protection of SGLT2 inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects diagnosed with T2D on stable antidiabetic medication\n* No recent use of SGLT2 inhibitor within 3 months\n\nExclusion Criteria:\n\n* HbA1c \\> 10%\n* Pregnancy or breast feeding\n* estimated GFR \\<45 30 mL/min/1.73㎡\n* insulin user'}, 'identificationModule': {'nctId': 'NCT05194592', 'briefTitle': 'Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'CR121038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin group', 'description': 'Dapagliflozin 10mg for 6 months.', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Gemigliptin group', 'description': 'Gemigliptin 50mg for 6 months.', 'interventionNames': ['Drug: Gemigliptin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.', 'armGroupLabels': ['Dapagliflozin group']}, {'name': 'Gemigliptin', 'type': 'DRUG', 'description': 'The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.', 'armGroupLabels': ['Gemigliptin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwondo', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong-Hyuk Cho, MD', 'role': 'CONTACT', 'email': 'why012@gmail.com', 'phone': '82-33-741-0916'}], 'facility': 'Yonsei University Wonju College of Medicine', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'centralContacts': [{'name': 'Dong-Hyuk Cho, MD,PhD', 'role': 'CONTACT', 'email': 'why012@gmail.com', 'phone': '82-33-741-0916'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dong-Hyuk Cho', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}