Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-02 @ 7:06 AM
Study NCT ID:
NCT00044668
Status:
COMPLETED
Last Update Posted:
2015-02-20
First Post:
2002-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2002-09-03', 'studyFirstSubmitQcDate': '2002-09-04', 'lastUpdatePostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit', 'timeFrame': 'Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52', 'description': 'Change in HbA1c from Baseline to Week 24, Week 52, and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)'}, {'measure': 'Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit', 'timeFrame': 'Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52', 'description': 'Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Visit 10 (Week 24), to Visit 14 (Week 52) and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exenatide', 'exendin-4', 'diabetes', 'Amylin', 'Lilly'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '22608106', 'type': 'DERIVED', 'citation': 'Ivanyi T, Fovenyi J, Faludi P, Han J, Macconell L, Wille S, Kiljanski J. Long-term effects of adding exenatide to a regimen of metformin and/or sulfonylurea in type 2 diabetes: an uncontrolled, open-label trial in Hungary. Clin Ther. 2012 Jun;34(6):1301-13. doi: 10.1016/j.clinthera.2012.04.022. Epub 2012 May 16.'}, {'pmid': '22236356', 'type': 'DERIVED', 'citation': 'Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with type 2 diabetes\n* Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination\n* BMI 25-45 kg/m\\^2\n* HbA1c between 7.5 % and 12.0 %, inclusive\n\nExclusion Criteria:\n\n* Treated with other oral anti-diabetic agents other than metformin and sulfonylureas within 3 months of screening\n* Patients previously treated with AC2993\n* Patients presently treated with insulin'}, 'identificationModule': {'nctId': 'NCT00044668', 'briefTitle': 'Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination', 'orgStudyIdInfo': {'id': '2993-117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC2993', 'description': '5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period', 'interventionNames': ['Drug: AC2993']}], 'interventions': [{'name': 'AC2993', 'type': 'DRUG', 'otherNames': ['synthetic exendin-4'], 'description': 'Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.', 'armGroupLabels': ['AC2993']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H 1036', 'city': 'Budapest', 'state': 'Hungary', 'country': 'Hungary', 'facility': 'Diagnostic Units Hungary Kft.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'H 1076', 'city': 'Budapest', 'state': 'Hungary', 'country': 'Hungary', 'facility': 'Peterfy Teaching Hospital', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'H 1145', 'city': 'Budapest', 'state': 'Hungary', 'country': 'Hungary', 'facility': 'Uzsoki Street Municipal Hospital', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Lisa Porter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amylin Pharmaceuticals, LLC.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}