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

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004775-38-DK

Enrollment

Registered

2008-05-20

Start date

2006-01-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with type 1 diabetes

Interventions

Product Name: Bifasisk insulin aspart 30 (BIAsp 30) Pharmaceutical Form: Solution for injection Product Name: Insulin Aspart Pharmaceutical Form: Solution for injection Product Name: Bifasisk Insuli

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Known or suspected allergy to the trial products or related products. - Recurrent major hypoglycaemic episodes. - Heart: Unstable Angina Pectoris, AMI 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.

Design outcomes

Primary

Measure	Time frame
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. A single centered, opened, randomised, quadruple cross-over trial. ;Secondary Objective: a) Area under the curve (AUC) glucose concentration: 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. b) AUC insulin aspart concentration: 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.	—

Measure

Time frame

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. A single centered, opened, randomised, quadruple cross-over trial. ;Secondary Objective: a) Area under the curve (AUC) glucose concentration: 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. b) AUC insulin aspart concentration: 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.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026