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

University of Aarhus

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin Aspart, BIAsp 70, BIAsp50, Human Insulin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00888732

Asp-BIAsp-HI-2008

2008-007176-22 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.