Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448070
• Other study ID #: NN729-1511
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2011
• Last updated: February 23, 2017
• Start date: October 15, 2002
• Est. completion date: December 20, 2002

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 show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 20, 2002
• Est. primary completion date: December 20, 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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 1 diabetes

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• human insulin
Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)

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	AUC (area under the curve) 0-8h (human insulin)
Primary	Cmax (maximum plasma concentration)
Primary	Area under the curve (glucose infusion rate (GIR)), 0-8h
Secondary	tmax (time to reach maximum)
Secondary	t½ (terminal half-life)
Secondary	GIR (glucose infusion rate) max
Secondary	tGIR (glucose infusion rate) max
Secondary	Area under the curve (C-peptide, 0-8h)
Secondary	Physical examinations and vital signs

External Links

•   Clinical Trials at Novo Nordisk