Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT01176656
Status:
COMPLETED
Last Update Posted:
2011-09-13
First Post:
2010-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypoglycemia: Physician and Patient Perspectives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-12', 'studyFirstSubmitDate': '2010-08-04', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of hypoglycemia and impact of hypoglycemia', 'timeFrame': 'October 2009-October 2010'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia)', 'timeFrame': 'October 2009-October 2010'}, {'measure': 'Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization', 'timeFrame': 'October 2009-October 2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Hypoglycemia'], 'conditions': ['Type 2 Diabetes Mellitus', 'Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with T2DM will be identified from a large U.S. administrative claims database using a claims-based algorithm for T2DM. Patients and their associated physicians will be recruited via mail into the survey portion of this study. Survey results will be linked to actual patient care using the claims records.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug\n* at least 1 HbA1c test recorded during the identification period\n* continuous enrollment in the health plan for at least 12 months prior to survey date\n\nExclusion Criteria:\n\n* Type 1 Diabetes Mellitus\n* pregnancy or gestational diabetes'}, 'identificationModule': {'nctId': 'NCT01176656', 'briefTitle': 'Hypoglycemia: Physician and Patient Perspectives', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Hypoglycemia: Physician and Patient Perspectives', 'orgStudyIdInfo': {'id': 'NIS-CUS-DUM-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SU', 'description': 'T2DM patients with a prescription for a sulfonylurea but no insulin'}, {'label': 'Antidiabetic without SU', 'description': 'T2DM patients with an oral antidiabetic drug other than an SU, and no insulin'}, {'label': 'Insulin', 'description': 'T2DM patients using insulin, with or without other oral antidiabetics'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Setareh Williams, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}