A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin
NCT ID: NCT00888732
Last Updated: 2011-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2009-06-30
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Insulin therapy
Insulin Aspart, Biphasic Insulin Aspart 70 and 50 \& Fast-acting Human Insulin
Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
0.2 U/IU/kg subcutaneous injection, single dose
Interventions
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Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin
0.2 U/IU/kg subcutaneous injection, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis.
* Insulin treatment of any regime for more than one year at time of inclusion.
* Total insulin demand ≥ 0,4 U/IU/kg/24 hrs
* HbA1c between 7% and 12% (both values included).
* Age ≥ 18 years.
* BMI between 18 and 35 kg /m2 (including both values).
Exclusion Criteria
* Recurrent major hypoglycaemic episodes.
* Heart: Unstable Angina Pectoris, AMI \< 12 months or heart insufficiency classified according to NYHA III-IV
* Blood Pressure: Severe uncontrolled hypertension with BP \> 180/110 mmHg, sitting
* Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase \> 2 x upper reference limit of the local laboratory.
* Kidneys: Impaired renal function corresponding to serum-creatinin \> 150 μmol/l according to the local laboratory.
* Any disease judged by the investigator to affect the trial.
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
University of Aarhus
OTHER
Responsible Party
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University of Aarhus
Principal Investigators
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Jens S Christiansen, M.D
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Dept of Medicine M, Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Click here for more information about trial site (Danish version only)
Other Identifiers
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2008-007176-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Asp-BIAsp-HI-2008
Identifier Type: -
Identifier Source: org_study_id
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