Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-03-21 @ 10:06 AM
Study NCT ID:
NCT02192450
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2014-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'C578220', 'term': 'insulin degludec, insulin aspart drug combination'}, {'id': 'C571886', 'term': 'insulin degludec'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2014-07-09', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic nocturnal hypoglycaemia', 'timeFrame': '9 months (3-12) of each treatment period'}], 'secondaryOutcomes': [{'measure': 'Severe hypoglycaemia (total, night-time, daytime)', 'timeFrame': '9 months (3-12) of each treatment period'}, {'measure': 'Any nocturnal hypoglycaemia (incl. asymptomatic/silent events)', 'timeFrame': '9 months (3-12) of each treatment period'}, {'measure': 'Any daytime hypoglycaemia (symptomatic, asymptomatic/silent and severe)', 'timeFrame': '9 months (3-12) of each treatment period'}, {'measure': 'Any CGM recorded hypoglycaemia (symptomatic, asymptomatic/silent and severe)', 'timeFrame': '2 x 6 days in each treatment arm'}, {'measure': 'Any in-hospital nocturnal hypoglycaemia (incl. asymptomatic/silent events)', 'timeFrame': '2 overnight stays in each treatment arm'}, {'measure': 'Change in HbA1c', 'timeFrame': 'From baseline to after 12 months of treatment'}, {'measure': 'Change in glycaemic variability', 'timeFrame': '4 x overnight stays and 4 x 6 days of CGM'}, {'measure': 'Insulin doses', 'timeFrame': 'End of each treatment period'}, {'measure': 'Quality of life incl. pre-depression scale', 'timeFrame': 'At baseline, cross-over and after 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Hypoglycaemia', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases', 'Autoimmune Diseases', 'Insulin', 'Hypoglycaemic Agents', 'Physiological Effetcs of Drugs'], 'conditions': ['Type 1 Diabetes Mellitus', 'Nocturnal Hypoglycemia', 'Recurrent Severe Hypoglycaemia']}, 'referencesModule': {'references': [{'pmid': '35467938', 'type': 'DERIVED', 'citation': 'Brosen JMB, Agesen RM, Alibegovic AC, Ullits Andersen H, Beck-Nielsen H, Gustenhoff P, Krarup Hansen T, Hedetoft CGR, Jensen TJ, Stolberg CR, Bogh Juhl C, Lerche SS, Norgaard K, Parving HH, Tarnow L, Thorsteinsson B, Pedersen-Bjergaard U. Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia. Diabetes Technol Ther. 2022 Sep;24(9):643-654. doi: 10.1089/dia.2021.0567. Epub 2022 Jun 22.'}, {'pmid': '31337371', 'type': 'DERIVED', 'citation': 'Agesen RM, Alibegovic AC, Andersen HU, Beck-Nielsen H, Gustenhoff P, Hansen TK, Hedetoft C, Jensen T, Juhl CB, Lerche SS, Norgaard K, Parving HH, Tarnow L, Thorsteinsson B, Pedersen-Bjergaard U. The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design. BMC Endocr Disord. 2019 Jul 23;19(1):78. doi: 10.1186/s12902-019-0408-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether insulin degludec compared to insulin glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the greatest potential benefit from optimised insulin treatment, which are patients with type 1 diabetes and high risk of nocturnal severe hypoglycaemia.', 'detailedDescription': 'Background: Insulin degludec is a novel insulin analogue that may reduce the risk of mild nocturnal hypoglycaemia in type 1 diabetes. Patients with type 1 diabetes and recurrent severe hypoglycaemia (high risk patients) are also burdened by nocturnal hyoglycaemia (mild and silent). These episodes may contribute to the developement of hormonal counterregulatory failure and hypoglycaemia unawareness, which in turn increases the risk of further hypoglycaemic episodes, especially epiosdes of severe hypoglycaemia.The effect of insulin degludec on risk of mild nocturnal hypoglycaemia in subjects with type 1 diabetes and high risk of severe hypoglycaemia compared to insulin glargine is to be investigated.\n\nStudy design and intervention: A controlled, cross-over multi-centre study in a Prospective, Randomised, Open, Blinded Endpoint (PROBE) design. Each treatment period last for 12 months. Patients will be randomised to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order. Endpoints will be assessed during the last 9 months of each treatment arm.\n\nSubjects: 175 type 1 diabetic patients with a history of one or more episodes of nocturnal severe hypoglycaemia during the proceeding two years.\n\nMethod: Patients will record all events of symptomatic (mild), asymptomatic (silent) and severe hypoglycaemia in a diary. All events of symptomatic nocturnal and severe hypoglycaemia must also be reported by telephone within 24 hours. Patients will be instructed to do and record self-monitored blood glucose (SMBG) i.e. 4-point profiles twice per week (blood glucose before breakfast, before lunch, before dinner and before bedtime).\n\nOutcomes: See "Outcome Measures". Concerning the primary endpoint all possible symptomatic nocturnal hypoglycaemic episodes will be adjudicated by an independent endpoint committee consisting of diabetes specialists blinded to the individual patient insulin regimen.\n\nSafety: Adverse reactions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes \\> 5 years\n* One or more episodes of nocturnal severe hypoglycaemia during the preceding two years\n* Treated with multiple dose insulin injection (\\>2) or insulin pump. Both human insulin and insulin analogues are allowed\n* Willingness to a once daily (OD) regimen concerning insulin degludec and insulin glargine\n* Willingness to do self-monitoring of blood glucose (SMBG) and keep a diary\n* Signed informed consent\n\nExclusion Criteria:\n\n* History of primary and secondary adrenal insufficiency, growth hormone deficiency, or untreated myxoedema\n* History of unstable angina or major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last three months)\n* Heart failure, New York Heart Association (NYHA) class IV\n* History of malignancy unless a disease-free period exceeding five years\n* History of alcohol or drug abuse\n* Treatment with glucose lowering agent(s) other than insulin\n* Pregnant or lactating women\n* Women of childbearing potential who are not using chemical (P-pills or gestagen depots) or mechanical (intra-uterine device) contraception\n* Participation in another investigational drug study within the last 3 months\n* Inability to understand the informed consent\n* HbA1c \\> 86 mmol/mol (10%)\n* Shifting working hours'}, 'identificationModule': {'nctId': 'NCT02192450', 'acronym': 'HypoDeg', 'briefTitle': 'Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'The Effect of Insulin Degludec on Risk of Symptomatic Nocturnal Hypoglycaemia in Subjects With Type 1 Diabetes and High Risk of Nocturnal Severe Hypoglycaemia', 'orgStudyIdInfo': {'id': 'HypoDeg'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin glargine', 'description': 'Each treatment arm last for 12 months - 3 months of run-in/cross-over and 9 months of maintenance.\n\nPatients will be randomised (1:1) to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order.\n\nAfter 12 months of treatment patients will cross-over to the other basal-bolus therapy.\n\nInsulin degludec and insulin glargine is administered once daily at the evening meal and insulin aspart is administered three times daily before the main meals.', 'interventionNames': ['Drug: Insulin aspart/glargine']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin degludec', 'description': 'Each treatment arm last for 12 months - 3 months of run-in/cross-over and 9 months of maintenance.\n\nPatients will be randomised (1:1) to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order.\n\nAfter 12 months of treatment patients will cross-over to the other basal-bolus therapy.\n\nInsulin degludec and insulin glargine is administered once daily at the evening meal and insulin aspart is administered three times daily before the main meals.', 'interventionNames': ['Drug: Insulin aspart/degludec']}], 'interventions': [{'name': 'Insulin aspart/glargine', 'type': 'DRUG', 'otherNames': ['NovoRapid', 'Lantus'], 'armGroupLabels': ['Insulin glargine']}, {'name': 'Insulin aspart/degludec', 'type': 'DRUG', 'otherNames': ['NovoRapid', 'Tresiba'], 'armGroupLabels': ['Insulin degludec']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hilleroed', 'country': 'Denmark', 'facility': 'Nordsjaellands Hospital'}], 'overallOfficials': [{'name': 'Ulrik Pedersen-Bjergaard, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nordsjaellands Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, {'name': 'Copenhagen University Hospital, Denmark', 'class': 'OTHER'}, {'name': 'Zealand University Hospital', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Esbjerg Hospital - University Hospital of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}