Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-01 @ 10:37 AM
Study NCT ID:
NCT02420392
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2015-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell
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': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2015-04-11', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion', 'timeFrame': 'From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp', 'description': 'Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp'}], 'secondaryOutcomes': [{'measure': 'First phase insulin/C-peptide response', 'timeFrame': 'From 0 to 10 minutes of hyperglycemic clamp'}, {'measure': 'Second phase insulin/C-peptide response', 'timeFrame': 'From 10 to 60 minutes of hyperglycemic clamp'}, {'measure': 'Area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp', 'timeFrame': 'From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp'}, {'measure': 'Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp', 'timeFrame': 'From 120 minutes to 180 minutes during GIP infusion under hyperglycemic clamp'}, {'measure': 'Difference of incretin sensitivity between diabetes patients and normal glucose tolerance subjects', 'timeFrame': 'From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp', 'description': 'Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp'}, {'measure': 'Difference of first phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects', 'timeFrame': 'From 0 to 10 minutes of hyperglycemic clamp'}, {'measure': 'Difference of second phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects', 'timeFrame': 'From 10 to 60 minutes of hyperglycemic clamp'}, {'measure': 'Difference of area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects', 'timeFrame': 'From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp'}, {'measure': 'Difference of Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects', 'timeFrame': 'From 120 minutes to 180 minutes during GIP infusion under hyperglycemic clamp'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta cell.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes for dapagliflozin arm\n* Normal glucose tolerance (fasting plasma glucose \\<100 mgd/l, HbA1c \\<6.0%) for normal glucose tolerance arm\n* Age 18 to 75 years\n* BMI \\<35 kg/m2\n* For type 2 diabetes patients, at least 3 months of treatment period and HbA1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea\n\nExclusion Criteria:\n\n* Who is allergic to dapagliflozin\n* Type 1 diabetes\n* Patients with history of diabetic ketoacidosis\n* Reduced renal function (eGFR \\<60ml/min/1.73m2)\n* Taking loop diuretics or dehydrated patient\n* History of hypotension when taking hypertensive medication\n* Diagnosed with heart failure\n* Diagnosed with cerebral infarction\n* Taking insulin, DPP-4 inhibitor, GLP-1 analogue, pioglitazone, alpha-glucosidase inhibitor\n* Above upper limit of normal hematocrit range (male 39-52%, female 36-48%)\n* Pregnant or breastfeeding women\n* History of recurrent genitourinary infection\n* AST/ALT more than two fold increased above normal upper limit\n* Hemolytic disorder'}, 'identificationModule': {'nctId': 'NCT02420392', 'briefTitle': 'Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell', 'orgStudyIdInfo': {'id': 'H1407-176-598'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin treatment', 'description': 'Test incretin sensitivity after dapagliflozin treatment in type 2 diabetes patients', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'NO_INTERVENTION', 'label': 'Normal glucose tolerance', 'description': 'Test incretin sensitivity in subjects with normal glucose tolerance'}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': '8 weeks treatment of dapagliflozin added to the type 2 diabetes patients with unsufficiently controlled with metformin or sulfonylurea', 'armGroupLabels': ['Dapagliflozin treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young Min Cho, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Young Min Cho', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}