Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process

Healthy Clinical Trial

Official title:

A Single Centre, Randomized, Balanced Double Blind, Cross-Over Trial Investigating the Bioequivalence of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486914
• Other study ID #: NN2000-1512
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2011
• Last updated: February 28, 2017
• Start date: January 19, 2003
• Est. completion date: February 24, 2003

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 insulin aspart produced by current process and the NN2000 process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 24, 2003
• Est. primary completion date: February 24, 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy

• Caucasian

• Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant

• Fasting blood glucose below or equal to 6 mmol/L

• Body mass index (BMI) 22.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

• Participated in another clinical study with an investigational drug within the last 4 weeks

• Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable

• Known or suspected allergy to the trial product or related products

• Family history of type 2 diabetes

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin aspart
Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Manchester

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 Curve (AUC) (insulin aspart)
Secondary	Cmax (maximum plasma concentration)
Secondary	Terminal half life (t½)
Secondary	Incident of hypoglycaemic episodes
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk