Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-27 @ 12:59 AM
Study NCT ID:
NCT01697657
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2012-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes
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'}], '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': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-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': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of total self-recorded hypoglycaemic episodes'}], 'secondaryOutcomes': [{'measure': 'Incidence of total major hypoglycaemic episodes'}, {'measure': 'HbA1c (glycosylated haemoglobin)'}, {'measure': '8-point plasma glucose profiles'}, {'measure': 'Serum glucose profiles'}, {'measure': '72-hours glucose profile'}, {'measure': 'Within-subject variation in home-measured fasting plasma glucose'}, {'measure': 'Incidence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '16842476', 'type': 'RESULT', 'citation': 'Kolendorf K, Ross GP, Pavlic-Renar I, Perriello G, Philotheou A, Jendle J, Gall MA, Heller SR. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet Med. 2006 Jul;23(7):729-35. doi: 10.1111/j.1464-5491.2006.01862.x.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes\n* Fasting c-peptide below lower limit of normal fasting range\n* Duration of type 1 diabetes for at least 12 months\n* Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections\n* HbA1c maximum 9.0% (using Biorad Variant method)\n* Able and willing to perform self-monitoring of blood glucose\n* Basal insulin requirement at least 30% of the total daily insulin dose\n* BMI (body Mass Index) maximum 35 kg/m\\^2\n\nExclusion Criteria:\n\n* Proliferative retinopathy or maculopathy requiring acute treatment\n* Total daily insulin dose above 1.4 IU/kg/day\n* Known unawareness of hypoglycaemia\n* Impaired hepatic function\n* Impaired renal function\n* Cardiac problems\n* Uncontrolled, treated/untreated hypertension\n* Known or suspected allergy to trial product or related products'}, 'identificationModule': {'nctId': 'NCT01697657', 'briefTitle': 'Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen', 'orgStudyIdInfo': {'id': 'NN304-1375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Detemir', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NPH', 'interventionNames': ['Drug: insulin NPH', 'Drug: insulin aspart']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2', 'armGroupLabels': ['Detemir']}, {'name': 'insulin NPH', 'type': 'DRUG', 'description': 'Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2', 'armGroupLabels': ['NPH']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2', 'armGroupLabels': ['Detemir', 'NPH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '5035', 'city': 'Ashford', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.94859, 'lon': 138.57457}}, {'zip': '3128', 'city': 'Box Hill', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '8000', 'city': 'Århus C', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'zip': '06012', 'city': 'Città di Castello', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.46556, 'lon': 12.2375}}, {'zip': '06126', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '7925', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '231 85', 'city': 'Trelleborg', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.37514, 'lon': 13.15691}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}