Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT05542420
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Research Study, Looking at the Characterization of Treatment Intensified (Add on to Metformin) Real-world Adult Population With Type 2 Diabetes Mellitus in India, Pakistan and Thailand.
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI (body mass index)', 'timeFrame': '6 months prior to Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class) (retrospective)', 'description': 'BMI will be calculated from height and weight data reported as percent of patients'}, {'measure': 'Most recent blood pressure measurement values', 'timeFrame': '6 months prior to Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class) (retrospective)', 'description': 'Reported as mmHg'}, {'measure': 'The proportion of patients prescribed glucagon-like peptide-1 receptor agonists (GLP-1 RA)', 'timeFrame': 'At Baseline (day 0, defined as the date of first prescription for the most recent antidiabetic medication drug class)', 'description': 'Will be reported as percent of patients'}, {'measure': 'The proportion of patients prescribed cardiovascular disease (CVD) medications', 'timeFrame': 'Since the start of medical record', 'description': 'Will be reported as percent of patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study aims to describe demographics, clinical, treatment and healthcare resource utilization characteristics with a particular focus on those relating to cardiovascular disease in selected treatment intensified patients with type 2 diabetes in the real-world settings in India, Pakistan, and Thailand.\n\nThe study will be based on data already recorded in participants medical record and no new tests or procedures are required as part of the study.\n\nThe study will last for about 6 months and it does not affect participants current treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients with T2DM fulfilling the inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n2. Male or female, age above or equal to 18 years at type 2 diabetes mellitus (T2DM) diagnosis\n3. Year of birth 1928 or later (age blow 90 years old in 2017)\n4. T2DM diagnosis in medical record on or after the date of local GLP-1 RA marketing authorization\n5. Medical records documenting prior or ongoing treatment with metformin\n6. Medical records documenting treatment with other non-metformin T2DM drugs\n\nExclusion Criteria:\n\n1. Previous participation in this study. Participation is defined as having given informed consent in this study.\n2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.\n3. Patients with any diagnosis of type 1 diabetes mellitus (T1DM)'}, 'identificationModule': {'nctId': 'NCT05542420', 'acronym': 'CONVERGE', 'briefTitle': 'A Research Study, Looking at the Characterization of Treatment Intensified (Add on to Metformin) Real-world Adult Population With Type 2 Diabetes Mellitus in India, Pakistan and Thailand.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multicentre Retrospective Study of Characterization of Treatment Intensified (Add on to Metformin) Real World Adult Population With Type 2 Diabetes Mellitus in India, Pakistan, and Thailand.', 'orgStudyIdInfo': {'id': 'DAS-7528'}, 'secondaryIdInfos': [{'id': 'U1111-1273-4446', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Real world adult population with type 2 diabetes mellitus (T2DM)', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'The study will be based on data already recorded in the medical record', 'armGroupLabels': ['Real world adult population with type 2 diabetes mellitus (T2DM)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengaluru', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': '"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}