Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT00809705
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2008-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2008-12-16', 'studyFirstSubmitQcDate': '2008-12-16', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tmax, log (AUC), log(Cmax)of paracetamol', 'timeFrame': 'Days -1, 1, 5, 29, 33, 78 and 82'}], 'secondaryOutcomes': [{'measure': 'Adverse events, laboratory parameters, vital signs', 'timeFrame': 'Throughout study'}, {'measure': 'renal function (creatinine clearance, urine volume and electrolytes)', 'timeFrame': 'Throughout study'}, {'measure': 'Multiple dose pharmacokinetics of Taspoglutide', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. 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': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-75 years of age;\n* type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for \\>=3 months prior to screening;\n* stable weight +/-10% for \\>=3 months before screening.\n\nExclusion Criteria:\n\n* type 1 diabetes mellitus;\n* acute gastrointestinal symptoms at screening and/or day -1;\n* clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.'}, 'identificationModule': {'nctId': 'NCT00809705', 'briefTitle': 'A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BP21572'}, 'secondaryIdInfos': [{'id': '2008-003575-47'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: taspoglutide']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: taspoglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'sc once weekly for 12 weeks', 'armGroupLabels': ['3']}, {'name': 'taspoglutide', 'type': 'DRUG', 'description': '10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks', 'armGroupLabels': ['2']}, {'name': 'taspoglutide', 'type': 'DRUG', 'description': '10mg sc once weekly for 12 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}, {'zip': 'HA1 3UJ', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}