Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 4:20 AM
Study NCT ID:
NCT01275794
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2011-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Epidemiological Program on Compensation Evaluation of Diabetes Mellitus Type 2 (DMT2) Patients on Oral Anti-diabetic (OAD) Monotherapy and Physicians Satisfaction of Their Usage
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1849}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-01', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy', 'timeFrame': '1 visit within 4 month'}, {'measure': 'To assess frequency of target levels of HbA1c ≤ 7% in patients with T2D during OAD monotherapy', 'timeFrame': '1 visit within 4 month'}], 'secondaryOutcomes': [{'measure': 'To assess fasting glycemia in patients with T2D on OAD monotherapy', 'timeFrame': '1 visit within 4 month'}, {'measure': 'To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy', 'timeFrame': '1 visit within 4 month'}, {'measure': "To evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D)", 'timeFrame': '1 visit within 4 month'}, {'measure': 'To compare the results of OAD monotherapy in different groups of patients', 'timeFrame': '1 visit within 4 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is assessment of glycemic control and physicians satisfaction with results of DM2 OAD monotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients have an established diagnosis of T2D\n* Experience of therapy with one OAD during the from 6 months to 5 years before the registration in the Program\n\nExclusion Criteria:\n\n* Experience of therapy with two or more OADs and/or insulin therapy and/or incretin mimetics (exenatide) at any time before registration in the Program\n* Absence of changes in HbAc1 level during the last year before registration in the Program'}, 'identificationModule': {'nctId': 'NCT01275794', 'briefTitle': 'Screening Epidemiological Program on Compensation Evaluation of Diabetes Mellitus Type 2 (DMT2) Patients on Oral Anti-diabetic (OAD) Monotherapy and Physicians Satisfaction of Their Usage', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage', 'orgStudyIdInfo': {'id': 'NIS-CRU-ONG-2010/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients have an established diagnosis of T2D, Age 35 years and more, Experience of therapy with one OAD during the from 6 months to 5 years before the registration in the Program'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'city': 'Astrakhan', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 46.34968, 'lon': 48.04076}}, {'city': 'Barnaul', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Izhevsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Khemerovo', 'country': 'Russia', 'facility': 'Research Site'}, {'city': 'Kirov', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'city': 'Kurgan', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.44905, 'lon': 65.34344}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'city': 'Perm', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Seversk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.60056, 'lon': 84.88639}}, {'city': 'Smolensk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'St-Peterburg', 'country': 'Russia', 'facility': 'Research Site'}, {'city': 'Tomsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'city': 'Tyumen', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'city': 'Ufa', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'city': 'Yoshkar-Ola', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.63877, 'lon': 47.89078}}], 'overallOfficials': [{'name': 'Alexey Stepanov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}