Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00806520
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2008-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2008-12-08', 'studyFirstSubmitQcDate': '2008-12-09', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Continuous Glucose Monitoring', 'Exenatide Once Weekly or', 'Januvia or', 'Actos'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Obtain Continuous Glucose Monitoring (CGM) data from individuals taking exenatide LAR, sitagliptin, or pioglitazone. The CGM measurements collected will help determine the characteristics of glucose control prior to treatment and during treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in the Amylin BCB106 Protocol Main Study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* type 2 diabetes\n* A1c 7.1 - 11\n* BMI 25 - 45\n* stable weight for 3 months before screening\n* fasting glucose \\< 280 at screening\n* stable dose of metformin for at least 2 months before screening\n* not being treated with or on a stable dose of hormone replacement therapy, oral contraceptives, anti-hypertensive agents, lipid lowering agents, thyroid replacement therapy, anti-depressants, drugs known to affect body weight\n* male or female, non-lactating, non-pregnant and willing to use birth control\n* lab values that are not clinically significant at screening\n* physical exam and ECG that are not clinically significant at screening\n* able to read, understand, and sign consent form\n\nExclusion Criteria:\n\n* liver disease\n* renal disease\n* cardiovascular disease\n* gastroparesis\n* cancer within 5 years of screening\n* macular edema\n* chronic infections\n* drug or alcohol abuse\n* fasting triglycerides \\> or = 600 at screening\n* previous exposure to exenatide LAR\n* has donated blood within 60 days of screening or is planning to donate during the study\n* has had a major surgery or blood transfusion within 2 months before screening\n* is currently being treated or is expecting to be treated with Byetta, Januvia, SU, TZD, GLP-1 analog, alpha-glucosidase inhibitor, meglitinide, nateglinide, symlin, insulin, systemic corticosteroids, lopid or rifampin\n* has received an investigational drug within 1 month before screening\n* has allergies or hypersensitivity to any component of the study drug\n* has previously had an adverse event related to TZD or Januvia\n* is an immediate family member of the study sight or directly affiliated\n* is employed by Amylin, Lilly or Alkermes'}, 'identificationModule': {'nctId': 'NCT00806520', 'briefTitle': 'Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control Addendum to: A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release to Those of Sitagliptin and Pioglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin (Study BCB106)', 'orgStudyIdInfo': {'id': '03671-08-C'}}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'International Diabetes Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Medical Group', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Diabetes Care Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Rockwood Clinic', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Richard M. Bergenstal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Diabetes Center at Park Nicollet'}, {'name': 'Roger S. Mazze, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Diabetes Center at Park Nicollet'}, {'name': 'Robert M. Cuddihy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Diabetes Center at Park Nicollet'}, {'name': 'Elinor (Ellie) S. Strock, APRN, BS,CDE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Diabetes Center at Park Nicollet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amylin Pharmaceuticals, LLC.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}