Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-03 @ 7:23 AM
Study NCT ID:
NCT03674866
Status:
COMPLETED
Last Update Posted:
2019-12-06
First Post:
2018-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Canadian Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571886', 'term': 'insulin degludec'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 662}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2018-09-05', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycated Haemoglobin (HbA1c)', 'timeFrame': 'Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec', 'description': 'measured in % point'}], 'secondaryOutcomes': [{'measure': 'Change in percentage of patients with HbA1c below 7%', 'timeFrame': 'Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec', 'description': 'percentage of patients'}, {'measure': 'Change in percentage of patients with HbA1c below 7.5%', 'timeFrame': 'Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec', 'description': 'percentage of patients'}, {'measure': 'Change in percentage of patients with HbA1c below 8.0%', 'timeFrame': 'Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec', 'description': 'percentage of patients'}, {'measure': 'Change in the mean Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec', 'description': 'measured in mmol/L'}, {'measure': 'Insulin degludec dose', 'timeFrame': 'At switch to insulin degludec (week 0)', 'description': 'measured in units/day'}, {'measure': 'Insulin degludec dose', 'timeFrame': '6 months after switch to insulin degludec', 'description': 'measured in units/day'}, {'measure': 'Change in the mean daily insulin doses (total, basal, prandial)', 'timeFrame': 'Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec', 'description': 'measured in units/day'}, {'measure': 'Change in the number of concomitant non-insulin glucose-lowering drug classes', 'timeFrame': 'Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec', 'description': 'number of concomitant non-insulin glucose-lowering drug classes'}, {'measure': 'Change in body weight', 'timeFrame': 'Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec', 'description': 'measured in kg'}, {'measure': 'Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)', 'timeFrame': 'Before change to insulin degludec (-6 to 0 months)', 'description': 'percentage of patients'}, {'measure': 'Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)', 'timeFrame': 'After change to insulin degludec (0 to 6 months)', 'description': 'percentage of patients'}, {'measure': 'Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)', 'timeFrame': 'Before change to insulin degludec (-6 to 0 months)', 'description': 'rates of hypoglycaemic episodes'}, {'measure': 'Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)', 'timeFrame': 'After change to insulin degludec (0 to 6 months)', 'description': 'rates of hypoglycaemic episodes'}, {'measure': 'Percentage of patients continuing insulin degludec', 'timeFrame': 'After change to insulin degludec (0 to 6 months)', 'description': 'percentage of patients'}, {'measure': 'Reason(s) for starting insulin degludec', 'timeFrame': 'At time of switch to insulin degludec (week 0)', 'description': 'Reasons for starting insulin degludec (if available) will be classified as: Not at glycaemic target, Hypoglycaemia (severe / non-severe / nocturnal), Hypoglycaemia unawareness, Multiple risk factors for hypoglycaemia (elderly, intensive exercise, Chronic Kidney Disease, other), Basal insulin dose more than 80 units/day, Twice daily basal insulin dosing, Fasting blood glucose variability, Need for flexible time of dosing, Device issue, other'}, {'measure': 'Reason(s) for discontinuing insulin degludec', 'timeFrame': 'At time of discontinuing insulin degludec (0 to 6 months)', 'description': 'Reasons for discontinuing insulin degludec (if applicable and available) will be classified as: Injection site reaction, Insufficient efficacy, Hypoglycaemia (severe / non-severe / nocturnal), Weight gain, Cost, Device issue, Other'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '33932223', 'type': 'DERIVED', 'citation': 'Harris SB, Ajala O, Bari B, Liutkus J, Hahn J, Martyn O, Zwicker D. Evaluating the Effectiveness of Switching to Insulin Degludec from Other Basal Insulins in a Real-World Canadian Population with Type 1 or Type 2 Diabetes: The CAN-TREAT Study. Diabetes Ther. 2021 Jun;12(6):1689-1702. doi: 10.1007/s13300-021-01063-5. Epub 2021 May 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect historical data in real life conditions in a large group of people who have type 1 or type 2 diabetes and were treated with Tresiba® (insulin degludec) for at least 6 months. Data will be collected beginning 6 months before the participant started Tresiba® up to around 6 months after the participant started taking insulin degludec.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 1 or type 2 diabetes mellitus whose basal insulin was switched to insulin degludec', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient\n* Male or female age greater than or equal to 18 years at the time of insulin degludec initiation\n* Type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus patients\n* Switched to insulin degludec (± prandial insulin) after any basal insulin (± prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with insulin degludec at the time of patient selection\n* Previously treated with any basal insulin (± prandial insulin) for at least 6 months prior to switching to insulin degludec\n* At least one documented medical visit in the first 6 months (closest value in 3 to 9 months window) after insulin degludec initiation\n* Minimum available data at the time of insulin degludec initiation: age, type of diabetes, HbA1c, duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site for at least 1 year, and an estimated glomerular filtration rate (eGFR) value in the last 12 ±6 months (full data period)\n\nExclusion Criteria:\n\n* Previous participation in this study. Participation is defined as having signed the Informed Consent in this study\n* Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba'}, 'identificationModule': {'nctId': 'NCT03674866', 'acronym': 'CAN-TREAT', 'briefTitle': 'A Canadian Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Canadian Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus CAN-TREAT (CANadian TREsiba AudiT)', 'orgStudyIdInfo': {'id': 'NN1250-4396'}, 'secondaryIdInfos': [{'id': 'U1111-1203-7872', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with diabetes', 'description': 'Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®).', 'interventionNames': ['Drug: Insulin degludec']}], 'interventions': [{'name': 'Insulin degludec', 'type': 'DRUG', 'description': 'Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.', 'armGroupLabels': ['Patients with diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2H 2G4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5T 3J7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6J 4Y3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B2T 1A4', 'city': 'Shubenacadie', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.08345, 'lon': -63.39869}}, {'zip': 'B1P 1P3', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.1351, 'lon': -60.1831}}, {'zip': 'L1Z 0M1', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'L6S 0C6', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'N1R 7L6', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'L4K 4M2', 'city': 'Concord', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.80011, 'lon': -79.48291}}, {'zip': 'M9R 4E1', 'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'N1H 3R3', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6G 2M1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3P 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'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'H2K 1H2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 2C6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3T2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4T 1Z9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H8Z 1W5', 'city': 'Pierrefonds', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 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