Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00924105
Status:
COMPLETED
Last Update Posted:
2012-02-13
First Post:
2009-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-10', 'studyFirstSubmitDate': '2009-06-16', 'studyFirstSubmitQcDate': '2009-06-17', 'lastUpdatePostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'continously'}], 'secondaryOutcomes': [{'measure': 'Biological measures of glycemia and inflammation', 'timeFrame': 'continously'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '26686385', 'type': 'DERIVED', 'citation': 'Cavelti-Weder C, Timper K, Seelig E, Keller C, Osranek M, Lassing U, Spohn G, Maurer P, Muller P, Jennings GT, Willers J, Saudan P, Donath MY, Bachmann MF. Development of an Interleukin-1beta Vaccine in Patients with Type 2 Diabetes. Mol Ther. 2016 May;24(5):1003-12. doi: 10.1038/mt.2015.227. Epub 2015 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting Interleukin-1 beta in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus, according to the American Diabetes Association diagnostic criteria, ≥ 3 months at time of randomization\n* HbA1c in the range of 6.5 - 9.5% (inclusive) at screening\n* Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 4 weeks prior to randomization\n* Further criteria as defined in the clinical trial protocol\n\nExclusion Criteria:\n\n* Symptoms of hyperglycemia (i.e. polyuria and polydypsia)\n* History of significant weight gain or loss (+/-5%) during the 4 weeks before randomization\n* Fasting C-peptide level \\< 400 pmol/L at screening\n* Change in the medicamentous treatment of elevated blood pressure, diabetes mellitus or dyslipidemia within 4 weeks prior to the randomization\n* Use of any weight loss medication (over the counter prescription) or initiation of a prescribed weight management or exercise program within 4 weeks before randomization\n* Current systemic anti-inflammatory therapy other than aspirin ≤ 100 mg/day or immunosuppressive treatment, in particular oral corticosteroids'}, 'identificationModule': {'nctId': 'NCT00924105', 'briefTitle': 'Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytos Biotechnology AG'}, 'officialTitle': 'A Two-Stage Randomized Placebo-controlled Ascending Dose Phase I/ IIa Study to Evaluate Safety, Tolerability, Pharmacodynamic Effects and Preliminary Efficacy of an Anti-Interleukin 1 Beta Vaccine (CYT013-IL1bQb) in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'CYT013-IL1bQb 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: CYT013-IL1bQb']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CYT013-IL1bQb', 'type': 'DRUG', 'description': 's.c. injection', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 's.c. injection', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'Cytos Investigator sites', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Cytos Investigator sites', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Cytos Investigator sites', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytos Biotechnology AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}