Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-02 @ 10:50 AM
Study NCT ID:
NCT00823992
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2009-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
Sponsor:
Organization:
Raw JSON
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Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 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 mellitus, receiving metformin at a stable dose of \\>=1500mg/day for at least 12 weeks;\n* HbA1c \\>=6.5% and \\<=9.5% at screening;\n* BMI \\>=30 and \\<=50 kg/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 or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;\n* evidence of clinically significant diabetic complications;\n* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT00823992', 'briefTitle': 'A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.', 'orgStudyIdInfo': {'id': 'BC22092'}, 'secondaryIdInfos': [{'id': '2008-005809-20'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'taspoglutide', 'interventionNames': ['Drug: taspoglutide']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'sc once weekly', 'armGroupLabels': ['placebo']}, {'name': 'taspoglutide', 'type': 'DRUG', 'description': '10mg sc once weekly for 4 weeks, then 20mg sc once weekly', 'armGroupLabels': ['taspoglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92203', 'city': 'Bermuda Dunes', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.7428, 'lon': -116.28918}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 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