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A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, BIAsp70, BIAsp50 and Fast-acting Human Insulin

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Jens S Christiansen, M.D, Principal Investigator, Affiliation: University of Aarhus

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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

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

tmaxins: Time to maximum serum insulin aspart/human insulin concentration

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)

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Informed consent obtained before any trial-related activities.

- 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:

- Known or suspected allergy to trial product(s) or related products.

- 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.

Locations and Contacts

Dept of Medicine M, Aarhus University Hospital, Aarhus 8000, Denmark
Additional Information

Click here for more information about trial site (Danish version only)

Related publications:

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.

Kang S, Creagh FM, Peters JR, Brange J, Vølund 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.

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. Review.

Jacobsen LV, Søgaard 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.

Starting date: June 2009
Last updated: April 27, 2011

Page last updated: August 23, 2015

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