Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-27 @ 4:41 AM
Study NCT ID:
NCT02230618
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune 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': 1029}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Weeks 0-52'}], 'secondaryOutcomes': [{'measure': 'Serious Adverse Events (SAEs)', 'timeFrame': 'Weeks 0-52'}, {'measure': 'Serious Adverse Drug Reactions (SADRs)', 'timeFrame': 'Weeks 0-52'}, {'measure': 'Adverse Drug Reactions (ADRs)', 'timeFrame': 'Weeks 0-52'}, {'measure': 'Severe or Blood glucose (BG) Confirmed hypoglycaemia', 'timeFrame': 'Weeks 0-52'}, {'measure': 'Change in HbA1c (glycosylated haemoglobin)', 'timeFrame': 'Week 0, week 52'}, {'measure': 'Change in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Week 0, week 52'}, {'measure': 'Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)', 'timeFrame': 'Week 0, week 52'}, {'measure': 'The reason for initiating or intensifying treatment with Ryzodeg™', 'timeFrame': 'Week 0 - week 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabetes where the treating physician has decided to start Ryzodeg™ according to routine clinical practice will qualify for starting treatment with Ryzodeg™.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any study-related activities. (Study-related activities are any procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be used for baseline data\n* Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician\n\nExclusion Criteria:\n\n* Known or suspected allergy to Ryzodeg™ any of the active substances or any of the excipients\n* Previous participation in this study\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation\n* Patients who are or have previously been on Ryzodeg™ therapy\n* Patients who are participating in other studies or clinical trials\n* Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months'}, 'identificationModule': {'nctId': 'NCT02230618', 'briefTitle': 'Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India', 'orgStudyIdInfo': {'id': 'NN5401-4149'}, 'secondaryIdInfos': [{'id': 'U1111-1157-0615', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': 'ENCEPP/SDPP/6587', 'type': 'REGISTRY', 'domain': 'EU PASS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ryzodeg™', 'interventionNames': ['Drug: insulin degludec/insulin aspart']}], 'interventions': [{'name': 'insulin degludec/insulin aspart', 'type': 'DRUG', 'description': 'Ryzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given.', 'armGroupLabels': ['Ryzodeg™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '522001', 'city': 'Guntur', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 16.29974, 'lon': 80.45729}}, {'zip': '520002', 'city': 'Vijayawada', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 16.50745, 'lon': 80.6466}}, {'zip': '530002', 'city': 'Visakhapatnam', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '380007', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380052', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 23.02579, 'lon': 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