Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00449605
Status:
TERMINATED
Last Update Posted:
2016-05-16
First Post:
2007-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'C057619', 'term': 'glimepiride'}, {'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': 508}}, 'statusModule': {'whyStopped': 'Company decision taken in light of demands by certain national health authorities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-13', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-13', 'studyFirstSubmitDate': '2007-03-19', 'dispFirstSubmitQcDate': '2016-04-13', 'studyFirstSubmitQcDate': '2007-03-19', 'dispFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in glycemic measure HbA1c', 'timeFrame': '52 weeks (1 year)'}], 'secondaryOutcomes': [{'measure': 'Absolute change from baseline in body weight', 'timeFrame': '52 weeks'}, {'measure': 'Relative change from baseline in HDL-C', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Metformin'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.\n\nThe main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.', 'detailedDescription': 'The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with legal age\n* Body Mass Index \\>27kg/m2\n* Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin \\>=1500 mg/day for at least three months\n* HbA1c \\>=7% and \\<=9% at screening visit\n\nExclusion Criteria:\n\n* Weight loss \\> 5 kg within three months prior to screening\n* Presence of any clinically significant endocrine disease according to the Investigator\n* Presence of type 1 diabetes\n* Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer\n* Previous participation in a clinical study with rimonabant\n* Absence of effective medical contraceptive method for females of childbearing potential\n* Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction\n* Within 2 months 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* 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, including uncontrolled serious psychiatric illness\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00449605', 'acronym': 'ALLEGRO', 'briefTitle': 'A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin', 'orgStudyIdInfo': {'id': 'EFC10007'}, 'secondaryIdInfos': [{'id': '2006-005385-39', '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': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride', 'description': 'Glimepiride from 1 mg up to 6 mg once daily on top of metformin', 'interventionNames': ['Drug: Glimepiride', 'Drug: Metformin']}], 'interventions': [{'name': 'Rimonabant', 'type': 'DRUG', 'otherNames': ['SR141716', 'Acomplia'], 'description': 'Tablet, oral administration', 'armGroupLabels': ['Rimonabant']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['HOE490', 'Amaryl'], 'description': 'Tablet, oral administration', 'armGroupLabels': ['Glimepiride']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin continued at stable dose as background therapy', 'armGroupLabels': ['Glimepiride', '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': 'Santiago', 'country': 'Chile', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Sanofi-aventis adminsitrative office', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Hørsholm', 'country': 'Denmark', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.88098, 'lon': 12.50111}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'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': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bromma', 'country': 'Sweden', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.34, 'lon': 17.94}}], 'overallOfficials': [{'name': 'ICD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}