Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-02 @ 3:24 AM
Study NCT ID:
NCT03888157
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 839}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glycated haemoglobin A1c (HbA1c) (percentage)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in percentage.'}, {'measure': 'Change in HbA1c (mmol/mol)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in mmol/mol.'}], 'secondaryOutcomes': [{'measure': 'Change in body weight (kilogram)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in kilogram.'}, {'measure': 'Change in body weight (percentage)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in percentage.'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in centimetres.'}, {'measure': 'Change in fasting blood glucose (FBG) (self-measured)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in mg/dL.'}, {'measure': 'Change in total cholesterol (TC)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in mg/dL.'}, {'measure': 'Change in low density lipoprotein cholesterol (LDL-C)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in mg/dL.'}, {'measure': 'Change in high density lipoprotein cholesterol (HDL-C)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in mg/dL.'}, {'measure': 'Change in triglyceride (TG)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in mg/dL.'}, {'measure': 'Change in free fatty acid (FFA)', 'timeFrame': 'Week 0, week 26', 'description': 'Measured in mg/dL.'}, {'measure': 'Number of patients permanently discontinuing treatment with Victoza®', 'timeFrame': 'Week 26', 'description': 'Number of patients.'}, {'measure': 'Reasons for permanent treatment discontinuations', 'timeFrame': 'Week 26', 'description': 'Number of occurrence of pre-specified events.'}, {'measure': 'Changes in quality of life (EQ-5D index score)', 'timeFrame': 'Week 0, week 26', 'description': "Quality of life will be measured with the EQ-5D-5L instrument's index score. The EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems). The outcome will be presented as EQ-5D index values using the United Kingdom (UK) value set."}, {'measure': 'Changes in quality of life (EQ VAS)', 'timeFrame': 'Week 0, week 26', 'description': 'Quality of life will be measured by EQ-5D-5L instrument\'s EQ visual analogue scale (EQ VAS). The EQ VAS records the patient\'s self-rated health on a vertical visual analogue scale. The scale is numbered from 0 to 100, where 0 indicates "worst" and 100 indicates "best". The outcome will be presented as EQ-5D VAS scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to collect information on how the medicine Victoza® (liraglutide) works in people with Type 2 diabetes in Iran. Patients will get Victoza® as prescribed to them by their study doctor. The study will last for about 5 to 8 months. Patients will be asked to complete some questionnaires about their health and diabetes treatment. Patients will complete these during their normally scheduled visits with study doctor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with T2DM in Iran judged by the study doctor for whom Victoza® is indicated are eligible to participate in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)\n* Male or female, age greater than or equal to 18 years at the time of signing informed consent\n* The decision to initiate treatment with commercially available Victoza® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study\n* Patients diagnosed with type 2 diabetes mellitus (T2DM), with treatment planned according to the Iranian label for Victoza® at treatment initiation\n* Available glycated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of treatment with Victoza®\n\nExclusion Criteria:\n\n* Previous participation in this study. Participation is defined as having given informed consent in this study\n* Known or suspected hypersensitivity to Victoza® or related products\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation'}, 'identificationModule': {'nctId': 'NCT03888157', 'acronym': 'VIEW-Iran', 'briefTitle': 'A Research Study Looking at How Victoza® Works in People With Type 2 Diabetes in Iran, Followed in Local Clinical Routine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multi-centre, Prospective, Non-interventional Study Investigating the Effect of Victoza® in Patients With Type 2 Diabetes in Iran Followed in a Real World Setting', 'orgStudyIdInfo': {'id': 'NN2211-4438'}, 'secondaryIdInfos': [{'id': 'U1111-1213-4238', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liraglutide', 'description': 'Patients with type 2 diabetes in Iran are to receive Victoza® for 26 weeks.', 'interventionNames': ['Drug: Liraglutide']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza®'], 'description': "Patients will be treated according to the Iranian label for Victoza®, following routine clinical practice and at the discretion of the study doctor. The study doctor will determine the intended maintenance dose of Victoza®, as well as any changes to the maintenance dose thereafter. Patients will be treated according to the Iranian label for Victoza®, following routine clinical practice and at the discretion of the study doctor. The study doctor will determine the intended maintenance dose of Victoza®, as well as any changes to the maintenance dose thereafter. The physician's decision to initiate treatment with Victoza® is clearly separate from the opportunity to include the patient in the study.", 'armGroupLabels': ['Liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ahvāz', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.31901, 'lon': 48.6842}}, {'city': 'Ardabil', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.2498, 'lon': 48.2933}}, {'city': 'Babol', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.55102, 'lon': 52.6786}}, {'city': 'Gorgan', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.8427, 'lon': 54.44391}}, {'city': 'Hamadan', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.79922, 'lon': 48.51456}}, {'city': 'Hormozgan', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site'}, {'city': 'Isfahan', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}, {'city': 'Islamshahr', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site'}, {'city': 'Karaj', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.83266, 'lon': 50.99155}}, {'city': 'Kerman', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.28321, 'lon': 57.07879}}, {'city': 'Mashahd', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site'}, {'city': 'Mashhad', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}, {'city': 'Sari', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.56332, 'lon': 53.06009}}, {'city': 'Shiraz', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Yazd', 'country': 'Iran', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.89722, 'lon': 54.3675}}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com/sharing-results', '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'}}}}