Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-02 @ 11:25 PM
Study NCT ID:
NCT01510093
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2012-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2012-01-11', 'studyFirstSubmitQcDate': '2012-01-11', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profiles of endogenous insulin and Insulin Aspart', 'timeFrame': '10 hours', 'description': 'Pharmacokinetic profiles of endogenous insulin and Insulin Aspart in type 2 diabetes melitus patients treated with continuous subcutaneous Insulin Aspart infusion by insulin pump and combined with or without intravenous supply of glucose'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamic glucose profiles', 'timeFrame': '10 hours', 'description': 'Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['type 2 diabetes mellitus, endogenous insulin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25785658', 'type': 'DERIVED', 'citation': 'Janukonyte J, Parkner T, Bruun NH, Lauritzen T, Christiansen JS, Laursen T. Interaction between exogenous insulin, endogenous insulin, and glucose in type 2 diabetes patients. Diabetes Technol Ther. 2015 May;17(5):335-42. doi: 10.1089/dia.2014.0326. Epub 2015 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised.\n\nHypotheses:\n\n1. Secretion of endogenous insulin depends on exogenous insulin supply\n2. Secretion of endogenous insulin is depends on plasma glucose levels', 'detailedDescription': 'There are a screening visit and two treatment sessions:\n\nSession A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with type 2 diabetes mellitus\n* Insulin-naive patients\n* HbA1C \\< 9%\n* Women and men \\>= 35 and \\<= 75 years old\n* BMI 25-42 kg/m2, both values are included\n\nExclusion Criteria:\n\n* Suspected or known allergy to the trial drug or similar medications\n* Treatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels\n* Heart: Unstable angina pectoris, acute myocardial infarction within the last 12 months\n* Severe uncontrolled hypertension with blood pressure in lying position \\> 180/110 mmHg\n* Impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory\n* Impaired kidney function with eGFR \\< 50 ml/min according to the local laboratory\n* Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.'}, 'identificationModule': {'nctId': 'NCT01510093', 'briefTitle': 'Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients', 'orgStudyIdInfo': {'id': '2011/1811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Insulin Aspart without glucose supply', 'description': 'Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply', 'interventionNames': ['Drug: Insulin Aspart 100 IE/ml']}, {'type': 'OTHER', 'label': 'Insulin Aspart with glucose supply', 'description': 'Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply', 'interventionNames': ['Drug: Insulin Aspart 100 IE/ml']}], 'interventions': [{'name': 'Insulin Aspart 100 IE/ml', 'type': 'DRUG', 'otherNames': ['NovoRapid 100 IE/ml'], 'description': '1.5 IE/hour/subject/visit. Each vist takes 10 hours', 'armGroupLabels': ['Insulin Aspart with glucose supply', 'Insulin Aspart without glucose supply']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Department of Endocrinology and Internal Diseases', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Jurgita Janukonyte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Jurgita Janukonyte', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}