Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT00690456
Status:
TERMINATED
Last Update Posted:
2016-05-18
First Post:
2008-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Rimonabant and Metformin Combination on Glycemic Control 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': 'D000077285', 'term': 'Rimonabant'}, {'id': 'D008687', 'term': 'Metformin'}], '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'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': 403}}, 'statusModule': {'whyStopped': 'Company decision taken in light of demands by certain national health authorities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-18', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2008-05-07', 'dispFirstSubmitQcDate': '2016-04-18', 'studyFirstSubmitQcDate': '2008-06-02', 'dispFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HbA1c', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in fasting plasma glucose', 'timeFrame': '36 weeks'}, {'measure': 'Change from baseline in body weight', 'timeFrame': '36 weeks'}, {'measure': 'Percent change from baseline in HDL-C and Triglycerides', 'timeFrame': '36 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Randomized Controlled Trial', 'Metformin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.\n\nSecondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.', 'detailedDescription': 'The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* History of type 2 diabetes\n* HbA1c between 7% to 10% at screening visit\n* Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit\n\nExclusion Criteria:\n\n* Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss\n* Weight loss of more than 5 kg within 3 months prior to screening\n* Administration of other investigational drugs within 30 days prior to screening visit\n* Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant\n* Presence or history of cancer within the past five years\n* Pregnant or breast-feeding women\n* Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00690456', 'acronym': 'TOCCATA', 'briefTitle': 'Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled Study Evaluating the Glycemic Effect of Rimonabant Added to Metformin in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy', 'orgStudyIdInfo': {'id': 'EFC10518'}, 'secondaryIdInfos': [{'id': '2007-004833-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rimonabant', 'description': 'Rimonabant 20 mg once daily on top of metformin', 'interventionNames': ['Drug: Rimonabant', 'Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (for Rimonabant) once daily on top of metformin', 'interventionNames': ['Drug: Placebo (for Rimonabant)', 'Drug: Metformin']}], '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': 'Metformin', 'type': 'DRUG', 'description': 'Metformin continued at stable dose as background therapy', 'armGroupLabels': ['Placebo', 'Rimonabant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Makati City', 'country': 'Philippines', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Brastislava', 'country': 'Slovakia', 'facility': 'Sanofi-Aventis Administrative Office'}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}