A comparison of pharmacodynamics and pharmacokinetics of Insulin Aspart and Biphasic Insulin Aspart 30, 50 og 70. A quadruple cross-over trial. - Asp-BIAsp-2005/0109

• Conditions: Patients with type 1 diabetes

• Registration Number: EUCTR2005-004775-38-DK
• Lead Sponsor: Medicinsk Afd. M, Århus Sygehus, Nørrebrogade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

- Informed consent.
- Diagnosed with type 1 diabetes before the age of 40.
- In treatment with any insulin > 1 year.
- Total insulin demand > 0,5 IU/kg/24 hrs.
- HbA1c between 7-12% (both included).
- Age > 18 years.
- BMI between 18-35 kg/m2 (both included).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known or suspected allergy to the trial products 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 by serum-creatinin > 150 µmol/l according to the local laboratory.
- Any disease judget by investigator to affect the trial.
- Pregnancy, breast feeding or intention of becoming pregnant or not using adequate contraceptive measures.
- The receipt of any inverstigational drug within a three month period prior to this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the pharmacodynamic (PD) and pharmacokinetic (PK) parameters for insulin aspart and biphasic insulin aspart 30, 50 and 70 over a period of 12 hours after a standard test meal.<br><br>A single centered, opened, randomised, quadruple cross-over trial.<br><br>;Secondary Objective: a) Area under the curve (AUC) glucose concentration:<br>0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after the test meal and single injection of insulin aspart, biphasic insulin aspart 30, 50 and 70.<br><br>b) AUC insulin aspart concentration:<br>0-12, 0-6, 6-12, 0-4, 4-8, 8-12 hours after the test meal and a single injection of insulin aspart, biphasic insulin aspart 30, 50 and 70.;Primary end point(s): The difference in the maximal value (Cmax) of plasma glucose following test meal and insulin injection for Insulin Aspart, Biphasic Insulin Aspart 30, 50 and 70.