Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT01906294
Status:
TERMINATED
Last Update Posted:
2016-04-11
First Post:
2013-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMS® DIAREG Diabetes Registry - Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2104}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Representativeness and results about treatment and health condition available', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-08', 'studyFirstSubmitDate': '2013-07-15', 'studyFirstSubmitQcDate': '2013-07-19', 'lastUpdatePostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'routine treatment data (composite of e.g. diagnostics, kind and dosage of pharmacological diabetes treatment)', 'timeFrame': 'From date of registration every 3 months until end of study (up to 120 months)', 'description': 'The objective of the project is to develop a sustainable Type 2 Diabetes Mellitus (T2DM) registry to collect daily routine treatment data (e.g. diagnostics, kind and dosage of pharmacological diabetes treatment) to provide a better understanding of the disease specific epidemiology, treatment patterns, patient relevant outcomes, patient subgroups, specifically among patients with Type 2 Diabetes Mellitus. Further DDG ("Deutsche Diabetes Gesellschaft") guideline adherence and economic aspects of diabetes treatment should be evaluated on the basis of this registry data.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This observation plan outlines the approach to build a diabetes registry to collect data on daily routine of treatment of Type 2 Diabetes Mellitus.', 'detailedDescription': "The choice to establish such a (general and specific) disease patient registry was based on several scientific and practical considerations as described in the AHRQ user's guide: registries for evaluating patient outcomes (www.ahrq.gov, 2007). From a public health point of view, such a register should monitor naturalistic (i.e., unbiased) use of diabetes treatment in the community and should primarily guide and assist medical professionals to make optimal choices in combating diabetes. The primary focus of this registry is therefore to monitor the medical and lifestyle treatment of diabetes in order to enable comparison of different treatment options and to provide data for future discussions of optimal treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Type 2 Diabetes Mellitus', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed written informed consent\n* Age of 18 years or older\n* Diagnosis of Type 2 Diabetes Mellitus (T2DM)\n\nExclusion Criteria:\n\nOnly patients who don't fulfill the inclusion criteria will be excluded. There will be no further possibility for the treating physician to exclude individual patients."}, 'identificationModule': {'nctId': 'NCT01906294', 'briefTitle': 'IMS® DIAREG Diabetes Registry - Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'IMS HEALTH GmbH & Co. OHG'}, 'officialTitle': 'Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '5050000'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 2 Diabetes Mellitus', 'description': 'Patients with antidiabetic treatment for Type 2 Diabetes Mellitus', 'interventionNames': ['Drug: antidiabetic treatment (ATC A10B)']}], 'interventions': [{'name': 'antidiabetic treatment (ATC A10B)', 'type': 'DRUG', 'armGroupLabels': ['Type 2 Diabetes Mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60325', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Praxis Dr. med. Birgit Böttger', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Stephan Martin, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Verbund der Katholischen Kliniken Düsseldorf (VKKD) Westdeutschen Diabetes- und Gesundheitszentrum (WDGZ)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IMS HEALTH GmbH & Co. OHG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}