Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-03-07 @ 2:04 PM
Study NCT ID:
NCT00108004
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105254', 'term': 'pramlintide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2005-04-12', 'studyFirstSubmitQcDate': '2005-04-12', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus', 'timeFrame': '6 months', 'description': 'To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.'}, {'measure': 'Understand management issues in subjects with type 1 and type 2 diabetes mellitus', 'timeFrame': '6 months', 'description': 'To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy'}]}, 'conditionsModule': {'keywords': ['Diabetes', 'Amylin', 'Symlin', 'pramlintide acetate'], 'conditions': ['Type 1 Diabetes Mellitus', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23748514', 'type': 'DERIVED', 'citation': 'Herrmann K, Frias JP, Edelman SV, Lutz K, Shan K, Chen S, Maggs D, Kolterman OG. Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy. Postgrad Med. 2013 May;125(3):136-44. doi: 10.3810/pgm.2013.05.2635.'}, {'pmid': '17425446', 'type': 'DERIVED', 'citation': 'Karl D, Philis-Tsimikas A, Darsow T, Lorenzi G, Kellmeyer T, Lutz K, Wang Y, Frias JP. Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight. Diabetes Technol Ther. 2007 Apr;9(2):191-9. doi: 10.1089/dia.2006.0013.'}, {'pmid': '17109671', 'type': 'DERIVED', 'citation': 'Edelman SV, Darsow T, Frias JP. Pramlintide in the treatment of diabetes. Int J Clin Pract. 2006 Dec;60(12):1647-53. doi: 10.1111/j.1742-1241.2006.01187.x.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.\n* The subject has a HbA1c of 7.0% to 11.0% at Screening.'}, 'identificationModule': {'nctId': 'NCT00108004', 'briefTitle': 'Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy', 'orgStudyIdInfo': {'id': '137-155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pramlintide', 'description': 'Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection.\n\nIt consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43-mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative', 'interventionNames': ['Drug: pramlintide acetate']}], 'interventions': [{'name': 'pramlintide acetate', 'type': 'DRUG', 'description': 'Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.', 'armGroupLabels': ['Pramlintide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Torrance', 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