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

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

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

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.

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.