Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-13 @ 2:18 AM
Study NCT ID:
NCT00478595
Status:
TERMINATED
Last Update Posted:
2016-06-06
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077285', 'term': 'Rimonabant'}], 'ancestors': [{'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 458}}, 'statusModule': {'whyStopped': 'Company decision taken in light of demands by certain national health authorities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'dispFirstSubmitDate': '2016-06-01', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-01', 'studyFirstSubmitDate': '2007-05-24', 'dispFirstSubmitQcDate': '2016-06-01', 'studyFirstSubmitQcDate': '2007-05-24', 'dispFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change from baseline in HbA1C', 'timeFrame': 'Baseline to week 52'}, {'measure': 'Relative change from baseline in in body weight', 'timeFrame': 'Baseline to week 52'}], 'secondaryOutcomes': [{'measure': 'Absolute change from baseline in Fasting Plasma Glucose', 'timeFrame': 'Baseline to week 52'}, {'measure': 'Absolute change from baseline in waist circumference', 'timeFrame': 'Baseline to week 52'}, {'measure': 'Relative change from baseline in Triglycerides and HDL-cholesterol', 'timeFrame': 'Baseline to week 52'}, {'measure': 'Safety: overview of adverse events', 'timeFrame': 'Baseline to Week 56'}]}, 'conditionsModule': {'keywords': ['obese', 'diabetes', 'cannabinoid-1 receptor'], 'conditions': ['Obesity', 'Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).\n\nThe secondary objectives are:\n\n* To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;\n* To evaluate the safety and tolerability of Rimonabant compared to placebo;\n* To evaluate the pharmacokinetics of Rimonabant.', 'detailedDescription': 'The total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor)\n* HbA1C ≥ 7.0 % and ≤ 10.0 %\n* Body Mass Index ≥ 25 kg/m²\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Within 12 weeks prior to screening visit: use of oral antidiabetic drugs (other than a sulfonylurea or alpha-glucosidase inhibitor) and/or insulin, of anti-obesity drugs or other drugs for weight reduction\n* Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment\n* Secondary obesity\n* Primary hyperlipidemia\n* Positive serum pregnancy test in females of childbearing potential\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00478595', 'acronym': 'SYMPHONY', 'briefTitle': 'Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients on Monotherapy Inadequately Controlled With Oral Anti-diabetic Drug', 'orgStudyIdInfo': {'id': 'EFC6647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rimonabant', 'description': 'Rimonabant 20 mg once daily', 'interventionNames': ['Drug: Rimonabant', 'Drug: Anti-diabetic monotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (for Rimonabant) once daily', 'interventionNames': ['Drug: Placebo (for Rimonabant)', 'Drug: Anti-diabetic monotherapy']}], 'interventions': [{'name': 'Rimonabant', 'type': 'DRUG', 'otherNames': ['SR141716', 'Acomplia'], 'description': 'Tablet, oral administration', 'armGroupLabels': ['Rimonabant']}, {'name': 'Placebo (for Rimonabant)', 'type': 'DRUG', 'description': 'Tablet, oral administration', 'armGroupLabels': ['Placebo']}, {'name': 'Anti-diabetic monotherapy', 'type': 'DRUG', 'description': 'Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period', 'armGroupLabels': ['Placebo', 'Rimonabant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}