Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT02967757
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2016-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-market Utilisation of Liraglutide Used for Weight Management in Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with BMI above or equal to 30 kg/m^2', 'timeFrame': 'Less than 6 months before date of first prescription'}, {'measure': 'Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity', 'timeFrame': 'Less than 6 months before date of first prescription', 'description': 'Dysglycaemia (Type 2 Diabetes Mellitus \\[T2DM\\] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities'}, {'measure': 'Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities', 'timeFrame': 'Less than 6 months before date of first prescription', 'description': 'Dysglycaemia (Type 2 Diabetes Mellitus \\[T2DM\\] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.'}, {'measure': 'Number of patients with BMI below 27 kg/m^2', 'timeFrame': 'Less than 6 months before date of first prescription'}, {'measure': 'Number of patients with BMI not measured', 'timeFrame': 'Within 6 months before date of the first prescription'}], 'secondaryOutcomes': [{'measure': 'Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day', 'timeFrame': 'From date of first prescription until 24 months'}, {'measure': 'Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management', 'timeFrame': 'From date of first prescription until 24 months'}, {'measure': 'Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg', 'timeFrame': 'By 12 weeks after first prescription date', 'description': 'While adhering to the dose escalation according to label'}, {'measure': 'Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg', 'timeFrame': 'From date of first prescription until 24 months', 'description': 'Number of patients'}, {'measure': 'Number of patients with continued treatment with liraglutide 3.0 mg', 'timeFrame': 'From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months', 'description': 'Number of patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolism and Nutrition Disorder', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '36514273', 'type': 'RESULT', 'citation': 'Sbraccia P, Aberle J, Olsen AH, Rathor N, Major-Pedersen A. Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. Diabetes Obes Metab. 2023 Apr;25(4):985-991. doi: 10.1111/dom.14945. Epub 2023 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a descriptive study designed to examine in-market utilisation of liraglutide; thus there will be no hypothesis testing and a power calculation is not applicable. 100 patients will be enrolled for the pilot study (50 in each country, ) and additionally 300 patients will be enrolled for the full study (150 in each country)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Initiation of liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg (initiation is defined as no prescription of the same brand within the previous 12 months)\n* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability of the study\n\nExclusion Criteria:\n\n-Patients or physicians who previously participated in interventional studies for liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the study -For the full study, sites and patients included in the pilot will be excluded'}, 'identificationModule': {'nctId': 'NCT02967757', 'briefTitle': 'In-market Utilisation of Liraglutide Used for Weight Management in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study.', 'orgStudyIdInfo': {'id': 'NN8022-4241'}, 'secondaryIdInfos': [{'id': 'U1111-1185-3661', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'EUPAS16225', 'type': 'REGISTRY', 'domain': 'EU PAS Register'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Patients will be treated according to routine clinical practice at the discretion of the treating physician. The study will gather data over the course of routine treatment for liraglutide 3.0 mg and liraglutide 1.2 mg/1.8 mg treated patients', 'armGroupLabels': ['liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '32257', 'city': 'Bünde', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.19837, 'lon': 8.58644}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '20097', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '67655', 'city': 'Kaiserslautern', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'zip': '55124', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81477', 'city': 'München', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48143', 'city': 'Münster', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '89073', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '95122', 'city': 'Catania', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '26900', 'city': 'Cremona', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '85100', 'city': 'Potenza', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'zip': '00128', 'city': 'Roma', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], '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'}}}}