Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 7:23 AM
Study NCT ID:
NCT00057304
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2003-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'C403084', 'term': 'BM 13.1258'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All potential participants entered the placebo run-in phase. At the end of the placebo run-in phase, eligible participants who met the final inclusion/exclusion criteria were randomized to the double-blind treatment period.\n\ntreatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2003-03-31', 'studyFirstSubmitQcDate': '2003-03-31', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 35 to 75\n* Type 2 diabetes for longer than 3 months\n* HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening\n* FPG (fasting plasma glucose) greater than 126 mg/dL at screening\n* BMI (body mass index) less than 40 kg/square meter\n\nExclusion Criteria:\n\n* Type I diabetes\n* Type 2 diabetes patients currently treated with insulin\n* Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin\n* FPG (fasting plasma glucose) greater than 270 mg/dL at baseline\n* Impaired liver or kidney function\n* Triglycerides greater than 600 mg/dL\n* Uncontrolled hypertension\n* Pregnant or lactating women\n* Women not using adequate contraception'}, 'identificationModule': {'nctId': 'NCT00057304', 'briefTitle': 'Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase II Randomized, Double-Blind, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'BM17151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RO 205-2349 2 mg QD', 'description': 'RO 205-2349 2 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.', 'interventionNames': ['Drug: RO 205-2349']}, {'type': 'EXPERIMENTAL', 'label': 'RO 205-2349 5 mg QD', 'description': 'RO 205-2349 5 mg was taken once daily (QD) for 16 weeks during the double-blind treatment period.', 'interventionNames': ['Drug: RO 205-2349']}], 'interventions': [{'name': 'RO 205-2349', 'type': 'DRUG', 'otherNames': 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