Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT01165268
Status:
COMPLETED
Last Update Posted:
2016-11-17
First Post:
2010-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2010-07-16', 'studyFirstSubmitQcDate': '2010-07-16', 'lastUpdatePostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin', 'timeFrame': 'Before 7 days of oral administration of 10 mg of dapagliflozin'}, {'measure': 'The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin', 'timeFrame': 'After 7 days of oral administration of 10 mg of dapagliflozin'}], 'secondaryOutcomes': [{'measure': 'Splay of the glucose titration curve', 'timeFrame': 'Before 7 days of oral administration of 10 mg of dapagliflozin'}, {'measure': 'Splay of the glucose titration curve', 'timeFrame': 'After 7 days of oral administration of 10 mg of dapagliflozin'}, {'measure': 'Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin', 'timeFrame': 'Study Day 7'}, {'measure': 'Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin', 'timeFrame': 'Study Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3651&filename=MB102-066_CSR_synopsis.pdf', 'label': 'MB102-066\\_CSR\\_synopsis'}]}, 'descriptionModule': {'briefSummary': 'It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for T2DM\n\n* Diagnosis of T2DM\n* Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin\n* Subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration\n* Must have a fasting plasma glucose concentration ≤ 200 mg/dl, and HbA1C ≤ 10%\n\nInclusion criteria for healthy subjects:\n\n* Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)\n\nInclusion criteria for all subjects:\n\n* Subjects with (eGFR ≥ 60 and ≤ 160 mL/min/1.73m² and urinary albumin excretion \\< 300 mg/g creatinine)\n* Body Mass Index (BMI) of 18 to 38 kg/m²\n* Men and women, ages 18 to 65 years, inclusive\n\nExclusion criteria for all subjects:\n\n* Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus\n* Subjects with T2DM with fasting plasma glucose \\> 200 mg/dL, healthy subjects with fasting plasma glucose \\> 105 mg/dL\n* Subjects with T2DM with HbA1C \\> 10.0%, healthy subjects with HbA1C \\> 6.8%'}, 'identificationModule': {'nctId': 'NCT01165268', 'briefTitle': 'Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'MB102-066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin (T2DM)', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin (Healthy Subjects)', 'interventionNames': ['Drug: Dapagliflozin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Tablets, Oral, 10 mg, Once daily, 7 days', 'armGroupLabels': ['Dapagliflozin (Healthy Subjects)', 'Dapagliflozin (T2DM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute For Clinical Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}