Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-29 @ 12:06 AM
Study NCT ID:
NCT00454233
Status:
COMPLETED
Last Update Posted:
2008-10-16
First Post:
2007-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects
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': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-14', 'studyFirstSubmitDate': '2007-03-29', 'studyFirstSubmitQcDate': '2007-03-29', 'lastUpdatePostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination)', 'timeFrame': '3 Months'}], 'secondaryOutcomes': [{'measure': 'Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel)', 'timeFrame': '3 Months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus Type 2', 'YM543', 'Treatment', 'Safety', 'efficacy'], 'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-naive subjects diagnosed with T2DM\n* Stable diet and exercise program for at least 6 weeks\n* Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1\n\nExclusion Criteria:\n\n* Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders\n* Use of insulin or oral blood glucose lowering drugs in the last 3 months'}, 'identificationModule': {'nctId': 'NCT00454233', 'briefTitle': 'A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double Blind, Placebo and Active Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Potential Efficacy of a 12-Week Treatment With YM543 in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '543-CL-003'}, 'secondaryIdInfos': [{'id': 'EudraCT number: 2006-001110-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Dose 1', 'interventionNames': ['Drug: YM543']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Dose 2', 'interventionNames': ['Drug: YM543']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Dose 3', 'interventionNames': ['Drug: YM543']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Dose 4', 'interventionNames': ['Drug: YM543']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '6', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'YM543', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['5']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': '4 Sites', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Nizhny Novgorod', 'country': 'Russia', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'city': 'Petrozavodsk', 'country': 'Russia', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': '10 Sites', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Disclosure Office Europe', 'oldOrganization': 'Astellas Pharma Europe BV'}}}}