Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01552005
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2012-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502994', 'term': 'saxagliptin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of Glycated hemoglobin (HbA1c) level, weight and the onset of hypoglycemic over time (2 years) for patients treated with Saxagliptin', 'timeFrame': '24 months', 'description': 'HbA1c level \\<7% at Y2, weight and assessment of hypoglycaemic events after a 2-year exposure to Saxagliptin'}, {'measure': 'Joint population of Saxagliptin based on socio-demographic data, medical history, disease history, comorbidities including renal, hepatic and cardiac functions, HbA1c level at treatment initiation)', 'timeFrame': 'One year (average)'}, {'measure': 'Utilization of Saxagliptin by General practitioners (GPs) and diabetologists in France (based on indication, initial dosage and adjustments, co-prescriptions, glycemic monitoring)', 'timeFrame': 'During the treatment (Up to 2 years)'}, {'measure': 'Retention rate of Saxagliptin and to describe discontinuation rate and reasons', 'timeFrame': 'At 2 years'}], 'secondaryOutcomes': [{'measure': 'Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies', 'timeFrame': '2 month'}, {'measure': "Saxagliptin utilization according to patient's profile and disease characteristics", 'timeFrame': '24 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2D)']}, 'referencesModule': {'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=3663&filename=CSR_D1680R00018_CV181_148.pdf', 'label': 'CSR\\_Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to respond to The French Health Authority which has requested BMS France and Astra Zeneca (AZ) France to set-up a long-term cohort study in a representative sample of French Type 2 Diabetes mellitus (T2D) patients treated with Saxagliptin to generate real world data on drug utilization, joint population, non comparative effectiveness and safety', 'detailedDescription': 'Time Perspective: Ambispective cohort follow by a 18 to 24 month follow up period, Retrospective follow by Prospective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be proposed by GPs and diabetologists in France to ambulatory patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registry\n\n * Patient ≥ 18 years old\n * Patient with T2D\n* Ambispective Cohort\n\n * Patient ≥ 18 years old\n * Patient with T2D\n * Patient initiated with Saxagliptin in the last 6 months before the inclusion or day of inclusion visit (whatever his/her ongoing hypoglycaemic treatment)\n * Patient agreeing to participate, and not yet enrolled by another physician\n\nExclusion Criteria:\n\n* Patient participating in a clinical trial'}, 'identificationModule': {'nctId': 'NCT01552005', 'acronym': 'DIAPAZON', 'briefTitle': 'Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France', 'orgStudyIdInfo': {'id': 'CV181-148'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Population of patients treated with Saxagliptin', 'interventionNames': ['Drug: Saxagliptin']}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'description': 'No Intervention', 'armGroupLabels': ['Population of patients treated with Saxagliptin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}