Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 5:30 AM
Study NCT ID:
NCT06399835
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis
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': 'C000729921', 'term': 'Enavogliflozin'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-05-03', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of HbA1c from the baseline', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Patients achieving HbA1c levels below 7%', 'timeFrame': '24 weeks', 'description': 'N and percentage of the patients'}, {'measure': 'Changes of body fat (whole body fat, abdominal fat)', 'timeFrame': '24 weeks', 'description': 'kg, %; measured with bioelectrical impedance analysis'}, {'measure': 'Changes of body weight', 'timeFrame': '12 weeks, 24 weeks'}, {'measure': 'Changes of glucose levels (fasting, 2-hour postprandial)', 'timeFrame': '12 weeks, 24 weeks', 'description': 'mg/dL'}, {'measure': 'Changes of systolic/diastolic blood pressures', 'timeFrame': '12 weeks, 24 weeks', 'description': 'mmHg'}, {'measure': 'Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)', 'timeFrame': '12 weeks, 24 weeks', 'description': 'mg/dL'}, {'measure': 'Changes of electrolytes (uric acid)', 'timeFrame': '12 weeks, 24 weeks', 'description': 'mg/dL'}, {'measure': 'Changes in parathyroid hormone', 'timeFrame': '12 weeks, 24 weeks', 'description': 'pg/mL'}, {'measure': 'Changes in 25-hydroxyl vitamin D3', 'timeFrame': '12 weeks, 24 weeks', 'description': 'ng/mL'}, {'measure': 'Changes of albuminuria', 'timeFrame': '12 weeks, 24 weeks', 'description': 'mg/g'}, {'measure': 'Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)', 'timeFrame': '12 weeks, 24 weeks', 'description': 'mg/dL'}, {'measure': 'Changes in ketone body', 'timeFrame': '12 weeks, 24 weeks', 'description': 'umol/L'}, {'measure': 'Changes of carotid intima-media thickness', 'timeFrame': '24 weeks', 'description': 'maximal thickness (mm)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes patients with a glycated hemoglobin (HbA1c) level of 7.0 - 10.5% at screening\n* Males or females aged 20-80 years\n* Individuals who have been taking Metformin (≥ 500mg) with or without a DPP-4 inhibitor (such as Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Gemigliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin) for at least the past 3 months\n* Body mass index ≥ 23 kg/m²\n* Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²\n\nExclusion Criteria:\n\n* Patients with Type 1 Diabetes, Gestational Diabetes, or secondary diabetes due to other causes\n* Patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit\n* Pregnant or breastfeeding patients, or patients not using contraception. Patients with chronic Hepatitis B or C (excluding healthy carriers of Hepatitis B), or liver disease (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\> 3 times the upper limit of normal)\n* Patients with heart failure or a history of heart failure\n* Individuals with a history of cancer within the past 5 years (excluding those adequately treated for squamous cell carcinoma or thyroid cancer)\n* Patients who have participated in another clinical study within the last 30 days\n* Alcohol addiction\n* Patients for whom the use of Enavogliflozin or Pioglitazone is contraindicated\n* Patients taking other oral hypoglycemic agents or insulin or other investigational drugs\n* Patients deemed unsuitable for the study based on the investigator's judgment"}, 'identificationModule': {'nctId': 'NCT06399835', 'briefTitle': 'Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'B-2310-859-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enavogliflozin', 'description': 'Enavogliflozin 0.3 mg', 'interventionNames': ['Drug: Enavogliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'description': 'Pioglitazone 15 mg', 'interventionNames': ['Drug: Pioglitazone']}], 'interventions': [{'name': 'Enavogliflozin', 'type': 'DRUG', 'otherNames': ['Envlo Tab.'], 'description': 'Enavogliflozin 0.3mg once daily', 'armGroupLabels': ['Enavogliflozin']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos Tab.'], 'description': 'Pioglitazone 15mg once daily', 'armGroupLabels': ['Pioglitazone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soo Lim', 'role': 'CONTACT', 'email': 'limsoo@snu.ac.kr', 'phone': '+82317877035', 'phoneExt': '82317877035'}, {'name': 'Minji Sohn', 'role': 'CONTACT', 'email': 'rainbowmjs@naver.com', 'phone': '+82317878443', 'phoneExt': '82317878443'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Soo Lim, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'limsoo@snu.ac.kr', 'phone': '+82317877035'}, {'name': 'Minji Sohn, Ph.D.', 'role': 'CONTACT', 'email': 'rainbowmjs@naver.com', 'phone': '+82317878443'}], 'overallOfficials': [{'name': 'Soo Lim, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Soo Lim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}