Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

Healthy Clinical Trial

Official title:

A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520831
• Other study ID #: BIASP-1086
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2012
• Last updated: January 3, 2017
• Start date: April 1999
• Est. completion date: May 2000

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2000
• Est. primary completion date: May 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Body mass index between 18 and 28 kg/m^2 inclusive

• HbA1c within the normal laboratory range

• Non smoker for at least three months

• Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion Criteria:

• Subjects who have received any investigational drug in the 3 months prior to the start of dosing

• Any disease requiring regular use of non topical prescription medicines

• Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug

• Any intercurrent illness or endocrine disorders that may affect blood glucose

• Subject with a history of drug or alcohol dependence

• Subject with a first degree relative with diabetes mellitus

• Subject with a history of clinically relevant allergic reactions to medical products

• Subjects who have donated any blood or plasma in the past 3 month preceding screening

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• biphasic insulin aspart 30
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
• biphasic insulin aspart 50
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
• biphasic insulin aspart 70
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
• insulin aspart
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Heise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes			No
Secondary	Maximum GIR value			No
Secondary	Time to maximum GIR value			No
Secondary	Area under the GIR profile			No
Secondary	Cmax, maximum insulin aspart concentration			No
Secondary	Area under the insulin aspart concentration curve			No
Secondary	tmax, the time to maximum insulin aspart concentration			No
Secondary	t½, terminal half-life			No

External Links

•   Clinical Trials at Novo Nordisk