Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
Study NCT ID:
NCT06592950
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Preference Study in Type-2 Diabetes Mellitus: Discrete Choice Experiment (DCE) to Support Novo Nordisk's Long-Acting Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 513}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T2DM patient preferences for a once weekly insulin treatment', 'timeFrame': 'Day of interview/survey completion (Day 1)', 'description': 'Pre-defined open-ended questions and Discrete Choice Experiment online survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type-2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'The primary objective of this research is to assess T2DM patient preferences for a once weekly insulin treatment. The study involves a qualitative interview phase and quantitative survey phase with a Discrete Choice Experiment (DCE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type-2 diabetes mellitus (T2DM) patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is an adult aged 18 years or over\n* Patient was diagnosed with type-2 diabetes mellitus (T2DM) greater than or equal to 180 days prior to the day of screening\n* Patient is currently prescribed a diabetes treatment (e.g., Metformin/Sus, DPP4i, SGLT2i, GLP-1 RA and/or basal insulin)\n* Patient is willing and able to provide written informed consent to participate\n\nFor qualitative interviews:\n\n* Patient is a fluent speaker of English and is able to read, write, and fully understand the English language\n* Patient is a resident in Canada\n\nFor quantitative online survey:\n\n* Patient is a fluent speaker of the local language (English/French/Spanish or Japanese) and is able to read, write and fully understand the local language\n* Patient is a resident of either Canada, France, Spain or Japan\n\nExclusion Criteria:\n\n* Patient is currently employing a basal-bolus insulin treatment regimen to manage their diabetes\n* Patient is unwilling or unable to comply with the needs of the study or has a physical, behavioural or mental condition that, in the opinion of the recruiter may affect the patient's ability to take part in the study, understand the nature, scope and possible consequences of the study, or the responses they might provide."}, 'identificationModule': {'nctId': 'NCT06592950', 'acronym': 'DCE', 'briefTitle': "Patient Preference Study in Type-2 Diabetes Mellitus: Discrete Choice Experiment (DCE) to Support Novo Nordisk's Long-Acting Insulin", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': "Patient Preference Study in Type-2 Diabetes Mellitus: Discrete Choice Experiment (DCE) to Support Novo Nordisk's Long-Acting Insulin", 'orgStudyIdInfo': {'id': 'DAS-7791'}, 'secondaryIdInfos': [{'id': 'U1111-1293-3919', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Quantitative online survey', 'description': 'Across four markets (Canada, France, Spain and Japan)', 'interventionNames': ['Other: No treatment given']}, {'label': 'Qualitative interviews', 'description': 'Conducted in Canada', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'Online survey', 'armGroupLabels': ['Quantitative online survey']}, {'name': 'No treatment given', 'type': 'OTHER', 'description': 'Interviews', 'armGroupLabels': ['Qualitative interviews']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2860', 'city': 'Søborg', 'country': 'Denmark', 'facility': 'Novo Nordisk', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}], 'overallOfficials': [{'name': 'Clinical Transparency dept. 2834', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://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'}}}}