Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 12:24 PM
Study NCT ID:
NCT00717457
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2008-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
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': 'D000077270', 'term': 'Exenatide'}, {'id': 'C541736', 'term': 'taspoglutide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-07-20', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2008-07-16', 'dispFirstSubmitQcDate': '2016-07-20', 'studyFirstSubmitQcDate': '2008-07-16', 'dispFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Fasting body weight', 'timeFrame': '24 weeks'}, {'measure': 'Proportion of patients reaching target HbA1c <=7.0%, <=6.5%', 'timeFrame': '24 weeks'}, {'measure': 'Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.', 'timeFrame': '24 weeks'}, {'measure': 'Beta cell function (proinsulin/insulin ratio)', 'timeFrame': '24 weeks'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '23139373', 'type': 'DERIVED', 'citation': 'Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \\>500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-75 years of age;\n* type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;\n* HbA1c \\>=7.0% and \\<=10% at screening;\n* BMI \\>=25kg/m2 (\\>23kg/m2 for Asians) and \\<=45kg/m2 at screening;\n* stable weight +/- 5% for at least 12 weeks prior to screening.\n\nExclusion Criteria:\n\n* history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;\n* history of acute metabolic diabetic complications within the previous 6 months;\n* evidence of clinically significant diabetic complications;\n* known proliferative diabetic retinopathy;\n* myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;\n* any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;\n* known hemoglobinopathy or chronic anemia;\n* clinically significant gastrointestinal disease.'}, 'identificationModule': {'nctId': 'NCT00717457', 'briefTitle': 'A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'BC21625'}, 'secondaryIdInfos': [{'id': '2008-001856-36'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'exenatide', 'interventionNames': ['Drug: exenatide']}, {'type': 'EXPERIMENTAL', 'label': 'taspoglutide 10mg', 'interventionNames': ['Drug: taspoglutide']}, {'type': 'EXPERIMENTAL', 'label': 'taspoglutide 10mg/20mg', 'interventionNames': ['Drug: taspoglutide']}], 'interventions': [{'name': 'exenatide', 'type': 'DRUG', 'description': '5mg twice daily for 4 weeks followed by 10mg twice daily', 'armGroupLabels': ['exenatide']}, {'name': 'taspoglutide', 'type': 'DRUG', 'description': '10mg once weekly', 'armGroupLabels': ['taspoglutide 10mg']}, {'name': 'taspoglutide', 'type': 'DRUG', 'description': '10mg once weekly for 4 weeks followed by 20mg once weekly', 'armGroupLabels': ['taspoglutide 10mg/20mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35565', 'city': 'Haleyville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.22649, 'lon': -87.62141}}, {'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United 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