Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT00790660
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2008-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
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': 'C572941', 'term': 'ipragliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'dispFirstSubmitDate': '2010-02-26', 'completionDateStruct': {'date': '2009-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-08', 'studyFirstSubmitDate': '2008-11-11', 'dispFirstSubmitQcDate': '2010-02-26', 'studyFirstSubmitQcDate': '2008-11-11', 'dispFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of safety through clinical safety labs and adverse events', 'timeFrame': '6 Weeks'}], 'secondaryOutcomes': [{'measure': 'Evaluation of routine PK and PD parameters', 'timeFrame': '6 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASP1941', 'Type 2 Diabetes Mellitus'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=3', 'label': 'Link to results on the Astellas Clinical Study Results website.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus', 'detailedDescription': 'Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established diagnosis of type 2 diabetes mellitus\n* HbA1c value between 7.0 and 10.0%\n* Body mass index between 20 and 45 kg/m2\n\nExclusion Criteria:\n\n* Established diagnosis of type 1 diabetes mellitus\n* Serum creatinine \\> upper limit of normal range\n* Proteinuria (microalbumin/creatinine ratio \\> 300 mg/g)\n* Urinary tract infection\n* Severe uncontrolled Hypertension\n* Significant renal, hepatic or cardiovascular disease\n* HIV Positive\n* History of drug or alcohol abuse/dependency'}, 'identificationModule': {'nctId': 'NCT00790660', 'briefTitle': 'A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1941-CL-0016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP1941 Lowest Dose', 'description': 'Oral', 'interventionNames': ['Drug: ASP1941']}, {'type': 'EXPERIMENTAL', 'label': 'ASP1941 Low Dose', 'description': 'Oral', 'interventionNames': ['Drug: ASP1941']}, {'type': 'EXPERIMENTAL', 'label': 'ASP1941 Medium Dose', 'description': 'Oral', 'interventionNames': ['Drug: ASP1941']}, {'type': 'EXPERIMENTAL', 'label': 'ASP1941 High Dose', 'description': 'Oral', 'interventionNames': ['Drug: ASP1941']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASP1941', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['ASP1941 High Dose', 'ASP1941 Low Dose', 'ASP1941 Lowest Dose', 'ASP1941 Medium Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'use Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}