Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 2:48 AM
Study NCT ID:
NCT00888732
Status:
COMPLETED
Last Update Posted:
2011-04-28
First Post:
2009-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D007328', 'term': 'Insulin'}], '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': 'D011384', 'term': 'Proinsulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-27', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmaxglu: Peak plasma glucose following test meal (breakfast). A comparison will be made between fast-acting human insulin vs. IAsp, BIAsp 50 and BIAsp 70, IAsp vs BIAsp 50 and BIAsp 70, BIAsp 50 vs. BIAsp 70.', 'timeFrame': '12 hours following a standard test meal (breakfast)'}], 'secondaryOutcomes': [{'measure': 'AUCglu: The area under the plasma glucose concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin', 'timeFrame': '12 hours following a standard test meal (breakfast)'}, {'measure': 'AUCins: The area under insulin aspart/human insulin concentration (0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after test meal) after a single injection of one of the four insulins: IAsp, Biphasic insulin aspart 50 and 70 & fast-acting human insulin', 'timeFrame': '12 hours following a standard test meal (breakfast)'}, {'measure': 'tmaxins: Time to maximum serum insulin aspart/human insulin concentration', 'timeFrame': '12 hours following a standard test meal (breakfast)'}, {'measure': 'Serum GH, total IGF-I, IGF-I bioactivity, IGFBP-1, IGFBP-2, binary complex of IGF-I, IGFBP-3 and the acid-labile subunit (ALS)', 'timeFrame': '12 hours following a standard test meal (breakfast)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '19175369', 'type': 'BACKGROUND', 'citation': 'Thorisdottir RL, Parkner T, Chen JW, Ejskjaer N, Christiansen JS. A comparison of pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30, 50, 70 and pure insulin aspart: a randomized, quadruple crossover study. Basic Clin Pharmacol Toxicol. 2009 Mar;104(3):216-21. doi: 10.1111/j.1742-7843.2008.00355.x. Epub 2009 Jan 20.'}, {'pmid': '9314644', 'type': 'BACKGROUND', 'citation': 'Weyer C, Heise T, Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care. 1997 Oct;20(10):1612-4. doi: 10.2337/diacare.20.10.1612.'}, {'pmid': '1914797', 'type': 'BACKGROUND', 'citation': 'Kang S, Creagh FM, Peters JR, Brange J, Volund A, Owens DR. Comparison of subcutaneous soluble human insulin and insulin analogues (AspB9, GluB27; AspB10; AspB28) on meal-related plasma glucose excursions in type I diabetic subjects. Diabetes Care. 1991 Jul;14(7):571-7. doi: 10.2337/diacare.14.7.571.'}, {'pmid': '11467325', 'type': 'BACKGROUND', 'citation': 'Thrailkill KM. Insulin-like growth factor-I in diabetes mellitus: its physiology, metabolic effects, and potential clinical utility. Diabetes Technol Ther. 2000 Spring;2(1):69-80. doi: 10.1089/152091599316775.'}, {'pmid': '11009049', 'type': 'BACKGROUND', 'citation': 'Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. doi: 10.1007/s002280000159.'}, {'pmid': '24725803', 'type': 'DERIVED', 'citation': 'Ma Z, Christiansen JS, Laursen T, Wu C, Lauritzen T, Parkner T, Frystyk J. Effects of human insulin and insulin aspart preparations on levels of IGF-I, IGFBPs and IGF bioactivity in patients with type 1 diabetes. BMC Endocr Disord. 2014 Apr 11;14:35. doi: 10.1186/1472-6823-14-35.'}, {'pmid': '22519735', 'type': 'DERIVED', 'citation': 'Ma Z, Parkner T, Frystyk J, Laursen T, Lauritzen T, Christiansen JS. A comparison of pharmacokinetics and pharmacodynamics of insulin aspart, biphasic insulin aspart 70, biphasic insulin aspart 50, and human insulin: a randomized, quadruple crossover study. Diabetes Technol Ther. 2012 Jul;14(7):589-95. doi: 10.1089/dia.2011.0299. Epub 2012 Apr 20.'}], 'seeAlsoLinks': [{'url': 'http://www.aarhussygehus.dk', 'label': 'Click here for more information about trial site (Danish version only)'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes', 'detailedDescription': 'This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 50, BIAsp 70 and Fast-acting Human Insulin after a standard test meal in subjects with type 1 diabetes. The profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of IAsp, BIAsp 50, BIAsp 70 or Fast-acting Human Insulin at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities.\n* Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.\n* Insulin treatment of any regime for more than one year at time of inclusion.\n* Total insulin demand ≥ 0,4 U/IU/kg/24 hrs\n* HbA1c between 7% and 12% (both values included).\n* Age ≥ 18 years.\n* BMI between 18 and 35 kg /m2 (including both values).\n\nExclusion Criteria:\n\n* Known or suspected allergy to trial product(s) or related products.\n* Recurrent major hypoglycaemic episodes.\n* Heart: Unstable Angina Pectoris, AMI \\< 12 months or heart insufficiency classified according to NYHA III-IV\n* Blood Pressure: Severe uncontrolled hypertension with BP \\> 180/110 mmHg, sitting\n* Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase \\> 2 x upper reference limit of the local laboratory.\n* Kidneys: Impaired renal function corresponding to serum-creatinin \\> 150 μmol/l according to the local laboratory.\n* Any disease judged by the investigator to affect the trial.\n* Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.'}, 'identificationModule': {'nctId': 'NCT00888732', 'briefTitle': 'A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 70 and 50 & Fast-acting Human Insulin in Patients With Type 1 Diabetes, A Randomised, Quadruple Crossover Trial', 'orgStudyIdInfo': {'id': 'Asp-BIAsp-HI-2008'}, 'secondaryIdInfos': [{'id': '2008-007176-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin therapy', 'description': 'Insulin Aspart, Biphasic Insulin Aspart 70 and 50 \\& Fast-acting Human Insulin', 'interventionNames': ['Drug: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin']}], 'interventions': [{'name': 'Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin', 'type': 'DRUG', 'otherNames': ['- Insulin Aspart: NovoRapid', '- BIAsp 50: NovoMix 50', '- BIAsp 70: NovoMix 70', '- Human Insulin: Actrapid'], 'description': '0.2 U/IU/kg subcutaneous injection, single dose', 'armGroupLabels': ['Insulin therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Dept of Medicine M, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Jens S Christiansen, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jens Sandahl Christiansen, M.D.', 'oldOrganization': 'University of Aarhus'}}}}