Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-29 @ 4:45 AM
Study NCT ID:
NCT01086306
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2010-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Hospitalized Infections Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatment
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': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113505}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-19', 'studyFirstSubmitDate': '2010-03-11', 'studyFirstSubmitQcDate': '2010-03-12', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the incidence of hospitalizations for infections among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of oral antidiabetic drug (OADs) in classes other than DPP4 inhibitors', 'timeFrame': '18 months'}, {'measure': 'To compare the incidence of hospitalizations for infections among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of oral antidiabetic drug (OADs) in classes other than DPP4 inhibitors', 'timeFrame': '36 months'}, {'measure': 'To compare the incidence of hospitalizations for infections among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of oral antidiabetic drug (OADs) in classes other than DPP4 inhibitors', 'timeFrame': '54 months'}, {'measure': 'To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction', 'timeFrame': '18 months', 'description': 'To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections\\[evaluated as a composite outcome\\]) among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors'}, {'measure': 'To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction', 'timeFrame': '36 months', 'description': 'To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections\\[evaluated as a composite outcome\\]) among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors'}, {'measure': 'To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction', 'timeFrame': '54 months', 'description': 'To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections\\[evaluated as a composite outcome\\]) among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors'}], 'secondaryOutcomes': [{'measure': 'A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies', 'timeFrame': '18 months'}, {'measure': 'A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies', 'timeFrame': '36 months'}, {'measure': 'A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies', 'timeFrame': '54 months'}, {'measure': 'Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)', 'timeFrame': '18 months'}, {'measure': 'Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)', 'timeFrame': '36 months'}, {'measure': 'Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)', 'timeFrame': '54 months'}, {'measure': 'Inpatient diagnoses of respiratory tract infections', 'timeFrame': '18 months'}, {'measure': 'Inpatient diagnoses of respiratory tract infections', 'timeFrame': '36 months'}, {'measure': 'Inpatient diagnoses of respiratory tract infections', 'timeFrame': '54 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '28878934', 'type': 'DERIVED', 'citation': 'Lo Re V, Carbonari DM, Saine ME, Newcomb CW, Roy JA, Liu Q, Wu Q, Cardillo S, Haynes K, Kimmel SE, Reese PP, Margolis DJ, Apter AJ, Reddy KR, Hennessy S, Bhullar H, Gallagher AM, Esposito DB, Strom BL. Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes. BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000400. doi: 10.1136/bmjdrc-2017-000400. eCollection 2017.'}, {'pmid': '25889498', 'type': 'DERIVED', 'citation': 'Saine ME, Carbonari DM, Newcomb CW, Nezamzadeh MS, Haynes K, Roy JA, Cardillo S, Hennessy S, Holick CN, Esposito DB, Gallagher AM, Bhullar H, Strom BL, Lo Re V 3rd. Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs. BMC Pharmacol Toxicol. 2015 Apr 2;16:8. doi: 10.1186/s40360-015-0007-z.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4450&filename=cv181_101.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the incidence of hospitalizations for infections among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those who are new initiators of Oral Anti-Diabetic Drug (OADs) in classes other than DPP4 inhibitors; and to compare the incidence of hospitalizations with infections associated with T-lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections \\[evaluated as a composite outcome\\]) among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors.', 'detailedDescription': 'Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be carried out using databases containing administrative claims data \\[HealthCore Integrated Research Database (HIRD) and Medicare in the U.S.\\] and electronic medical records \\[General Practice Research Database (GPRD) and The Health Improvement Network (THIN) in the UK\\]. The US population includes patients from health plans in the northeast, southeastern, mid-Atlantic, central, mid-western, and western regions (HIRD) as well as US citizens 65 years of age and older (Medicare). The UK population includes patients seeking medical care from general practitioners (GPRD and THIN)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Newly prescribed Saxagliptin \\[or an OAD in a class other than Dipeptidyl peptidase-4 (DPP4) inhibitors\\]\n* Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD\n\nExclusion Criteria:\n\n* Patients identified with a diagnostic code for inpatient diagnostic code for any of the infections of interest within the 180-day baseline period\n* Patients with DPP4 inhibitor exposure during the baseline period\n* Patients currently using exenatide or insulin'}, 'identificationModule': {'nctId': 'NCT01086306', 'briefTitle': 'Risk of Hospitalized Infections Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Comparison of Risk of Hospitalization for Infections Between Patients With Type 2 Diabetes Exposed to Saxagliptin and Those Exposed to Other Oral Anti-Diabetic Treatments', 'orgStudyIdInfo': {'id': 'CV181-101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients exposed to Saxagliptin'}, {'label': 'Patients exposed to oral antidiabetic drugs (not Saxagliptin)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}