Comparison of Two Formulations of Biphasic Insulin Aspart 70

Healthy Clinical Trial

Official title:

A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523041
• Other study ID #: BIASP-1144
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2012
• Last updated: February 22, 2017
• Start date: November 3, 1999
• Est. completion date: November 30, 1999

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.

Description:

Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 1999
• Est. primary completion date: November 30, 1999
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Caucasian

• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator

• Body mass index (BMI) between 19-27 kg/m^2

• Fasting plasma glucose between 3.8-6.0 mmol/L

Exclusion Criteria:

• Participation in any other clinical trial involving other investigational products within the last three months

• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin)
• biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin)
• biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin)

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin aspart curve in the interval from 0-24 hours
Secondary	Cmax, maximum insulin aspart concentration
Secondary	tmax, the time to maximum insulin aspart concentration
Secondary	t½, terminal half-life
Secondary	Cmin, minimum glucose concentration
Secondary	tmin, time to minimum concentration

External Links

•   Clinical Trials at Novo Nordisk