Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT00811460
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2008-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Taspoglutide in Type 2 Diabetic Patients
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': 'C541736', 'term': 'taspoglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2008-12-18', 'studyFirstSubmitQcDate': '2008-12-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incremental area under insulin concentration time curve relative to basal insulin concentration', 'timeFrame': 'First 10 minutes after glucose bolus'}], 'secondaryOutcomes': [{'measure': 'Incremental area under insulin concentration time curve relative to basal insulin concentration', 'timeFrame': '10-120 minutes after glucose bolus'}, {'measure': 'Adverse events, laboratory parameters', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is \\<3 months, and the target sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-65 years of age;\n* type 2 diabetes mellitus;\n* treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.\n\nExclusion Criteria:\n\n* type 1 diabetes mellitus;\n* type 2 diabetes duration of \\<3 months;\n* treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;\n* treatment with insulin for \\>7 days within 6 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT00811460', 'briefTitle': 'A Study of Taspoglutide in Type 2 Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Double-blind, Crossover, Randomized, Placebo-controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-phase Insulin Secretion in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'BP21844'}, 'secondaryIdInfos': [{'id': '2008-003582-97'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Placebo', 'Drug: taspoglutide']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'sc for 4 days', 'armGroupLabels': ['1']}, {'name': 'taspoglutide', 'type': 'DRUG', 'description': '300micrograms/day sc for 2 days', 'armGroupLabels': ['1']}, {'name': 'taspoglutide', 'type': 'DRUG', 'description': '800 micrograms/day sc for 2 days', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}