Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-01 @ 8:33 AM
Study NCT ID:
NCT01086293
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2010-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
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': 'Number of participants hospitalized with a diagnosis of acute liver failure', 'timeFrame': '18-months'}, {'measure': 'Number of participants hospitalized with a diagnosis of acute liver failure', 'timeFrame': '36-months'}, {'measure': 'Number of participants hospitalized with a diagnosis of acute liver failure', 'timeFrame': '54-months'}], 'secondaryOutcomes': [{'measure': 'Deaths due to acute liver failure', 'timeFrame': '18, 36 and 54 months'}, {'measure': 'Hospitalizations with acute liver failure and/or death due to acute liver failure', 'timeFrame': '18, 36 and 54 months'}, {'measure': 'Hospitalizations with acute liver injury', 'timeFrame': '18, 36 and 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=4451&filename=cv181_100.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the incidence of hospitalization with acute liver failure among patients with type 2 diabetes who are new users of Saxagliptin and those who are new users of other oral antidiabetic drugs.', '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 DatabaseSM (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 Oral Antidiabetic Drug (OAD) in a class other than Dipeptidyl peptidase IV (DPP4) inhibitors\n* Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD\n* Have at least one diagnostic code for a type 2 diabetes-related condition\n\nExclusion Criteria:\n\n* Patients identified with a diagnostic code for acute liver failure within the 180-day baseline period\n* Patients with DPP4 inhibitor exposure during the baseline period'}, 'identificationModule': {'nctId': 'NCT01086293', 'briefTitle': 'Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Comparison of Risk of Hospitalization With Acute Liver Failure Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments', 'orgStudyIdInfo': {'id': 'CV181-100'}}, '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'}}}}