Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

Healthy Clinical Trial

Official title:

A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620450
• Other study ID #: NN2000-1612
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2012
• Last updated: February 28, 2017
• Start date: November 20, 2004
• Est. completion date: February 26, 2005

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 Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 26, 2005
• Est. primary completion date: February 26, 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Japanese

• Considered generally healthy based on medical history and physical examination

• Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)

• Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria:

• Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis

• Any serious systemic infectious disease that occurred during the last 4 weeks before trial

• Any inter-current illness that may affect blood glucose

• Subject with a first degree relative with diabetes mellitus

• Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• biphasic human insulin 30
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)		From 0 to 16 hours after injection
Primary	Maximum insulin aspart concentration (Cmax IAsp)
Secondary	Area under the curve of insulin aspart concentration (AUC IAsp)
Secondary	Time to maximum insulin aspart concentration (tmax IAsp)
Secondary	Terminal elimination half life (t½)
Secondary	Body weight
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk