Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 6:04 PM
Study NCT ID:
NCT00325650
Status:
TERMINATED
Last Update Posted:
2016-05-18
First Post:
2006-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], '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'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, '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': 2420}}, 'statusModule': {'whyStopped': 'Company decision taken in light of demands by certain national health authorities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-19', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2006-05-12', 'dispFirstSubmitQcDate': '2016-04-19', 'studyFirstSubmitQcDate': '2006-05-12', 'dispFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of progression to type 2 diabetes', 'timeFrame': 'Baseline to 30 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in body weight', 'timeFrame': 'Baseline to 30 months'}, {'measure': 'Change from baseline in waist circumference', 'timeFrame': 'Baseline to 30 months'}, {'measure': 'Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin)', 'timeFrame': 'Baseline to 30 months'}, {'measure': 'Change from baseline in glucose and insulin at 2 hour post-glucose load', 'timeFrame': 'Baseline to 30 months'}, {'measure': 'Change from baseline in HDL-Cholesterol and triglycerides (TG)', 'timeFrame': 'Baseline to 30 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prediabetic state', 'Impaired fasting glucose', 'Impaired glucose Tolerance'], 'conditions': ['Prediabetic State']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nTo evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or both at baseline).\n\nSecondary objectives:\n\n* To assess the effect on weight loss and weight maintenance; sustained effect following a washout period, effect on other markers of glycemic control (fasting glucose, fasting-insulin and HbA1c), glucose tolerance and insulin responses during oral glucose tolerance tests (OGTTs), and on other risk factors (HDL-Cholesterol, TG),\n* To assess the effect on quality of life\n* To evaluate long term safety and tolerability.', 'detailedDescription': 'The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* No previous history of treatment for type 2 diabetes.\n* Diagnosis of :\n\n * Impaired Glucose Tolerance (IGT) based on one oral glucose tolerance test (OGTT) and defined as a 2 hour post-challenge glucose (after a 75-g Oral Glucose Tolerance Test) \\> 140 mg/dL (7.8 mmol/L) but \\< 200 mg/dL (11.1 mmol/L), at the screening visit.\n * And / or impaired fasting glucose (IFG) based on a Fasting Plasma Glucose (FPG) ³ 100 mg/dL (5.6 mmol/L) and \\< 126 mg/dL (7.0 mmol/L), at the screening visit.\n\nExclusion Criteria:\n\n* Absence of effective contraceptive method for females of childbearing potential.\n* Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit.\n* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.\n* Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.\n* Related to laboratory findings:\n\n * positive test for hepatitis B surface antigen and/or hepatitis C antibody;\n * Positive urine pregnancy test in females of childbearing potential ;\n * Thyroid-stimulating hormone (TSH) and free T4 outside central laboratory normal range.\n* Related to previous or concomitant medications:\n\n * Within 3 months prior to screening visit and/or during the screening period:\n\n * anti-obesity drugs (e.g., sibutramine, orlistat, herbal preparations, etc),\n * systemic long-acting corticosteroids; prolonged use (more than 10 days) of systemic corticosteroids;"}, 'identificationModule': {'nctId': 'NCT00325650', 'acronym': 'RAPSODI', 'briefTitle': 'Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Long-term Administration of Rimonabant in the Prevention of Type 2 Diabetes in Patients With Prediabetic Status (i.e., Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Both)', 'orgStudyIdInfo': {'id': 'EFC5107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rimonabant', 'description': 'Rimonabant 20 mg once daily', 'interventionNames': ['Drug: Rimonabant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (for Rimonabant) once daily.', 'interventionNames': ['Drug: Placebo (for Rimonabant)']}], '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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}