Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00490893
Status:
TERMINATED
Last Update Posted:
2007-06-25
First Post:
2007-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-22', 'studyFirstSubmitDate': '2007-06-22', 'studyFirstSubmitQcDate': '2007-06-22', 'lastUpdatePostDateStruct': {'date': '2007-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hormone response to hypoglycemia (Glucagon)'}, {'measure': 'Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia'}], 'secondaryOutcomes': [{'measure': 'Hormone response to glucagon (epinephrine, growth hormne, cortisol)'}, {'measure': 'Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['counterregulation', 'hypoglycemia unawareness', 'insulin therapy'], 'conditions': ['Diabetes Mellitus', 'Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects male or female\n* Age 18-50 years\n* Female subjects save contraception\n* Ability to take part in the study\n* Signed consent\n\nExclusion Criteria:\n\n* Chronic disease\n* Acute disease during 4 weeks prior to the study\n* Pregnancy\n* Drug treatment other than hormonal contraception'}, 'identificationModule': {'nctId': 'NCT00490893', 'briefTitle': 'Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia', 'orgStudyIdInfo': {'id': '2005-003940-79'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Detemir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tübingen, Medical Department', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Andreas Fritsche, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}}}}