Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT00042458
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2002-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2002-07-30', 'studyFirstSubmitQcDate': '2002-07-31', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.', 'timeFrame': '29 Weeks'}], 'secondaryOutcomes': [{'measure': '- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.', 'timeFrame': '29 Weeks'}, {'measure': '- To examine the pattern of daily insulin use over the course of the study.', 'timeFrame': '29 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HbA1c value between 7.5-9%\n* Using multiple daily insulin injections'}, 'identificationModule': {'nctId': 'NCT00042458', 'briefTitle': 'Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy', 'orgStudyIdInfo': {'id': '137-150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pramlintide Acetate (AC137)', 'description': 'Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It 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. The strength of pramlintide injection is 0.6 mg/mL', 'interventionNames': ['Drug: Pramlintide acetate']}], 'interventions': [{'name': 'Pramlintide acetate', 'type': 'DRUG', 'description': 'Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.', 'armGroupLabels': ['Pramlintide Acetate (AC137)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85204', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ana Ventures LLC', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Endocrinology Clinic, Ltd.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Clinical Trial Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Diabetes Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes Research Institute', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Medical Research Institute', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Childhood Diabetes', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Clinical Research Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Research Unlimited', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Research Unlimited', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Internal Medicine Associates', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Clinical Research', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Clinic", 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60411', 'city': 'Chicago Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'St. James Diabetes Center', 'geoPoint': {'lat': 41.50615, 'lon': -87.6356}}, {'city': 'Chicago Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'St. James Diabetes Center', 'geoPoint': {'lat': 41.50615, 'lon': -87.6356}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Outpatient Clinical Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21012', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Joslin Diabetes Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Grand Rapids Associated Interns', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Diabetes Care Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Univ.-Division of Endocrinology, Diabetes', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Camp Hill', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Physicians for Clinical Research', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'North Texas Clinical Research', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '75904', 'city': 'Lufkin', 'state': 'Texas', 'country': 'United States', 'facility': 'Private Practice', 'geoPoint': {'lat': 31.33824, 'lon': -94.7291}}, {'city': 'Lufkin', 'state': 'Texas', 'country': 'United States', 'facility': 'Private Practice', 'geoPoint': {'lat': 31.33824, 'lon': -94.7291}}, {'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}