Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT04656106
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2020-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (Glycosylated Hemoglobin)', 'timeFrame': 'Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)', 'description': 'Percentage point'}], 'secondaryOutcomes': [{'measure': 'Patients with HbA1c less than 7.0 percentage (Yes or No)', 'timeFrame': 'At baseline (week 0)', 'description': 'Percentage of patients'}, {'measure': 'Patients with HbA1c less than 7.0 percentage (Yes or No)', 'timeFrame': 'End of study (week 26)', 'description': 'Percentage of patients'}, {'measure': 'Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)', 'timeFrame': 'At baseline (week 0)', 'description': 'Percentage of patients'}, {'measure': 'Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No)', 'timeFrame': 'End of study (week 26)', 'description': 'Percentage of patients'}, {'measure': 'Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®', 'timeFrame': 'Period 1(week-26 to week 0), Period 2(week 0 to week 26)', 'description': 'Number of events'}, {'measure': 'Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg®', 'timeFrame': 'Period 1(week-26 to week 0), Period 2(week 0 to week 26)', 'description': 'Number of events'}, {'measure': 'Change in FPG (Fasting Plasma Glucose)', 'timeFrame': 'Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)', 'description': 'mmol/L'}, {'measure': 'Change in daily total insulin dose', 'timeFrame': 'Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)', 'description': 'Unit/day'}, {'measure': 'Change in daily basal insulin dose', 'timeFrame': 'Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)', 'description': 'Unit/day'}, {'measure': 'Change in daily prandial insulin dose', 'timeFrame': 'Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)', 'description': 'Unit/day'}, {'measure': 'Change in body weight', 'timeFrame': 'Period 1 (week -26 to week 0), Period 2 (week 0 to week 26)', 'description': 'Kg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '38410023', 'type': 'DERIVED', 'citation': 'Kang S, Ahn YB, Oh TK, Lee WY, Chun SW, Bae B, Dahaoui A, Jeong JS, Jung S, Jang HC. Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus. Diabetes Metab J. 2024 Sep;48(5):929-936. doi: 10.4093/dmj.2023.0297. Epub 2024 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD).\n\nAll patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation\n* Type 2 diabetes mellitus patients\n* Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg®\n* Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD)\n* At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation\n* Minimum available data : age, type of diabetes at the time of Ryzodeg® initiation, HbA1c \\[Three values: most recent value within 26 weeks (plus/minus 6 weeks) prior to Ryzodeg® initiation, a value of Ryzodeg® initiation date (plus/minus 6 week), and a value in the first 26 weeks (plus/minus 6 weeks) after Ryzodeg® initiation\\]\n* The decision to treat with Ryzodeg® was taken by treating physician independently from decision to include patient in study.\n\nExclusion Criteria:\n\n* Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg®\n* Patients switching to Ryzodeg® below 26 weeks prior to the data collection date\n* Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg®\n* Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg®\n* Pregnancy patient\n* Patients not treated with the local licensed Ryzodeg®'}, 'identificationModule': {'nctId': 'NCT04656106', 'briefTitle': 'A Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Retrospective Multi-centre Non-interventional Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea', 'orgStudyIdInfo': {'id': 'NN5401-4653'}, 'secondaryIdInfos': [{'id': 'U1111-1257-2534', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ryzodeg', 'description': 'Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®.', 'interventionNames': ['Drug: Ryzodeg®']}], 'interventions': [{'name': 'Ryzodeg®', 'type': 'DRUG', 'description': 'All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea. Hence independently of this study, the treating physician has determined the starting dose of Ryzodeg® as well as any dose adjustments thereafter.', 'armGroupLabels': ['Ryzodeg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330-721', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '361-711', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '463-707', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16247', 'city': 'Suwon-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Novo Nordisk Investigational Site'}], 'overallOfficials': [{'name': 'Clinical transparency (dept. 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'}}}}