Viewing Study NCT00067951


Ignite Creation Date: 2025-12-24 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
Study NCT ID: NCT00067951
Status: COMPLETED
Last Update Posted: 2018-03-21
First Post: 2003-09-03
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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': 'C471074', 'term': 'rosiglitazone-metformin combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10-17'}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2004-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2003-09-03', 'studyFirstSubmitQcDate': '2003-09-04', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperglycemia', 'HbA1c', 'Hemoglobin A1c', 'Type 2 diabetes mellitus'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': '712753/004', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '712753/004', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '712753/004', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '712753/004', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '712753/004', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '712753/004', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '712753/004', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laboratory result for HbA1c \\>11% or FPG \\>270mg/dL\n* Clinical diagnosis of Type II diabetes\n* Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.\n\nExclusion Criteria:\n\n* Women who are pregnant'}, 'identificationModule': {'nctId': 'NCT00067951', 'briefTitle': 'A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-controlled Subjects 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