Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT02066766
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2014-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1631}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}], 'secondaryOutcomes': [{'measure': 'Mean Fasting Plasma Glucose (FPG) of patients', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}, {'measure': 'Mean Postprandial Plasma Glucose (PPG) of patients', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}, {'measure': 'Mean HbA1c of patients', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}, {'measure': 'Proportion of patients having dyslipidemia', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}, {'measure': 'Proportion of patients having hypertension', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}, {'measure': 'Proportion of patients having cardiovascular complications', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}, {'measure': 'Proportion of patients having peripheral vascular disease', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}, {'measure': 'Proportion of patients having diabetic nephropathy', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}, {'measure': 'Proportion of patients having diabetic eye complications', 'timeFrame': 'Evaluated at the first visit (only one study visit)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Nguyen KT, Diep BTT, Nguyen VKD, Lam HV, Tran KQ, Tran NQ. A cross-sectional study to evaluate diabetes management, control and complications in 1631 patients with type 2 diabetes mellitus in Vietnam (DiabCare Asia). Int J Diabetes Dev Ctries 2019 [Epub ahead of print] DOI: 10.1007/s13410-019-00755-w'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Vietnam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People having been treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months\n* Patients willing to sign informed consent form\n\nExclusion Criteria:\n\n* Previous participation in this study\n* Unable to comply with protocol requirements\n* Confirmed or suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT02066766', 'acronym': 'DiabCare Asia', 'briefTitle': 'A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam', 'orgStudyIdInfo': {'id': 'INS-4069'}, 'secondaryIdInfos': [{'id': 'U1111-1137-2575', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with diabetes mellitus (type 2)', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'Patients will fill out a questionnaire by interview.', 'armGroupLabels': ['Subjects with diabetes mellitus (type 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}