Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-02 @ 2:37 PM
Study NCT ID:
NCT03745157
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2018-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESILIENT: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in Local Clinical Practice in Japan
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': 'C578220', 'term': 'insulin degludec, insulin aspart drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2018-11-14', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in local laboratory measured glycosylated haemoglobin (HbA1c)', 'timeFrame': 'From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in %point'}], 'secondaryOutcomes': [{'measure': 'Change in total insulin dose', 'timeFrame': 'From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in units/day'}, {'measure': 'Change in basal insulin dose', 'timeFrame': 'From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in units/day'}, {'measure': 'Change in prandial insulin dose', 'timeFrame': 'From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in units/day'}, {'measure': 'Change in local laboratory measured fasting plasma glucose (FPG)', 'timeFrame': 'From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in mg/dL'}, {'measure': 'The incidence of patient recollection of non-severe hypoglycaemic episodes', 'timeFrame': 'Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in episodes/person-year'}, {'measure': 'The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes', 'timeFrame': 'Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in episodes/person-year'}, {'measure': 'The incidence of patient recollection of overall severe hypoglycaemic episodes', 'timeFrame': 'Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in episodes/person-year'}, {'measure': 'The incidence of patient recollection of nocturnal severe hypoglycaemic episodes', 'timeFrame': 'Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)', 'description': 'Measured in episodes/person-year'}, {'measure': 'Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL)', 'timeFrame': 'From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)', 'description': 'Score (on a scale from 0-100, where 100 is the highest health related quality of life (HRQoL))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '34304385', 'type': 'DERIVED', 'citation': 'Shigiyama F, Liu L, Nordahl H, Suzuki R, Yamamoto Y, Hirose T. A Real-World, Prospective, Non-interventional Study of Adults with T2D Switching to IDegAsp from Glargine U100 or U300 in Japan. Diabetes Ther. 2021 Sep;12(9):2405-2421. doi: 10.1007/s13300-021-01117-8. Epub 2021 Jul 25.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to collect information on how Ryzodeg® works in real world participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes requiring insulin therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol\n* The decision to initiate treatment with commercially available insulin Ryzodeg® has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study\n* Male or female, age more than or equal to 20 years (the legal age of adulthood) at the time of signing informed consent\n* Diagnosed with type 2 diabetes (T2D) for at least 26 weeks prior to signing informed consent\n* Available and documented glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to initiation of Ryzodeg® treatment\n* For at least 26 weeks prior to initiation of Ryzodeg® treatment, one of the following must apply: A) Treated with insulin glargine (IGlar) (any formulation, including biosimilar IGlar). B) Treated with IGlar (any formulation, including biosimilar IGlar) and IGlar U300 for at least 12 weeks prior to initiation of Ryzodeg®\n\nExclusion Criteria:\n\n* Previous participation in this study. Participation is defined as signed informed consent.\n* Pregnancy\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation\n* Hypersensitivity to Ryzodeg® or to any of the excipients\n* Previously treated with Ryzodeg®'}, 'identificationModule': {'nctId': 'NCT03745157', 'acronym': 'RESILIENT', 'briefTitle': 'RESILIENT: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in Local Clinical Practice in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Prospective Non-interventional Study Investigating the Treatment Effect of Switching From Insulin Glargine to Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real World Adult Population With Type 2 Diabetes in Japan', 'orgStudyIdInfo': {'id': 'NN5401-4441'}, 'secondaryIdInfos': [{'id': 'U1111-1208-5143', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Type 2 Diabetes requiring insulin therapy', 'description': 'Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar)', 'interventionNames': ['Drug: Insulin Degludec/Insulin Aspart']}], 'interventions': [{'name': 'Insulin Degludec/Insulin Aspart', 'type': 'DRUG', 'description': 'Patients will be treated with commercially available Insulin Degludec/Insulin Aspart (Ryzodeg®) in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the treating physician in accordance with the Ryzodeg® label in Japan', 'armGroupLabels': ['Patients with Type 2 Diabetes requiring insulin therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116-0012', 'city': 'Arakawa-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '103-0002', 'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '819-0006', 'city': 'Fukuoka-shi, Fukuoka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '963-8851', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Higashiosaka-shi, Osaka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '062-0007', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '927-0053', 'city': 'Hosu-gun, Ishikawa', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.42333, 'lon': 127.82139}}, {'zip': '235-0045', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '247-0055', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '350-0851', 'city': 'Kawagoe-shi, Saitama', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '332-0012', 'city': 'Kawaguchi-shi, Saitama', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '292-0038', 'city': 'Kisarazu-shi, Chiba', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '114-0001', 'city': 'Kita-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '390-8621', 'city': 'Nagano', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '336-0963', 'city': 'Saitama-shi, Saitama', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 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{'lat': 34.98333, 'lon': 138.38333}}, {'zip': '223-0066', 'city': 'Yokohama-shi, Kanagawa', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', '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'}}}}