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Sponsors and Collaborators: |
University of Aarhus Novo Nordisk |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00283218 |
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.
OBJECTIVE:
The objective is to describe pharmacodynamic (PD) and pharmacokinetic (PK) profiles of Insulin Aspart (IAsp), Biphasic Insulin Aspart (BIAsp) 30, 50 and 70 for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes.
Condition | Intervention |
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Type 1 Diabetes |
Drug: NovoRapid, NovoMix 30, Bifasisk Insulin Aspart 50, BIAsp70 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70. - A Randomised, Quadruple Cross-Over Trial |
Estimated Enrollment: | 24 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | August 2006 |
This trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of IAsp, BIAsp 30, BIAsp 50 and BIAsp 70 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 30, BIAsp 50 or BIAsp 70 at a test meal. The trial consists of a screening period of 4-21 days and 4 treatment visits
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark, C | |
Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44 | |
Aarhus, C, Denmark, 8000 |
Principal Investigator: | Jens S Christiansen, M.D. | Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C |
Study Director: | Tina Parkner, M.D. | Medicinsk Afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C |
Study Director: | Niels Ejskjaer, M.D. | Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C |
Study Director: | Rannveig L Thorisdottir, Stud.med | Medicinsk afd. M, Århus Sygehus, Nørrebrogade 44, 8000 Århus C |
Study ID Numbers: | Asp-BIAsp-2005/0109 |
Study First Received: | January 26, 2006 |
Last Updated: | August 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00283218 |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: Danish Dataprotection Agency |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Insulin, Asp(B28)- Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |