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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborator: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

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.