A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility 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 ≥ 0,5 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 > 2x 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. The receipt of any investigational drug within a three month period prior to this trial.
Sites / Locations
- Dept of Medicine M, Aarhus University Hospital, Nørrebrogade 44