Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01017302
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2009-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2009-11-19', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of various doses of RO5095932', 'timeFrame': 'Weeks 1-4, 6, 8'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability of a single dose of RO5095932', 'timeFrame': 'Week 5, 6, 8'}, {'measure': 'Pharmacokinetics: blood concentration', 'timeFrame': 'Weeks 1-4, 6, 8'}, {'measure': 'Pharmacodynamics: glucose, insulin, C-peptide', 'timeFrame': 'Weeks 1-4, 6, 8'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is \\<6 months. The target sample size is \\<100 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, 18-65 years of age\n* Diabetes mellitus, type 2 for at least 6 months before screening\n* On treatment with stable doses of metformin for at least 3 months before screening\n* BMI between \\>/=25 and \\</=39\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Pancreatitis\n* Treatment with insulin for more than one week within 3 months prior to study start'}, 'identificationModule': {'nctId': 'NCT01017302', 'briefTitle': 'A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy', 'orgStudyIdInfo': {'id': 'NP22709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: RO5095932']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: RO5095932']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutenaous once weekly for 4 weeks', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single subcutaneous dose in week 5', 'armGroupLabels': ['4']}, {'name': 'RO5095932', 'type': 'DRUG', 'description': 'Escalating subcutaneous doses once weekly over a 4 weeks period', 'armGroupLabels': ['1']}, {'name': 'RO5095932', 'type': 'DRUG', 'description': 'Single subcutenaous dose in week 5', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}