Comparison of Two NN1250 Formulations in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966368
• Other study ID #: NN1250-1988
• Secondary ID: U1111-1122-29922
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2009
• Last updated: September 24, 2015
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: September 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator

• Body mass index 18.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)

• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin degludec
Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)
• insulin degludec
Single dose of NN1250, formulation 2, 0.4U/kg body weight injected subcutaneously (under the skin)

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose		From 0 to 120 hours after dosing	No
Primary	Maximum observed Insulin Degludec concentration after single dose		From 0 to 120 hours after dosing	No
Secondary	Time to maximum observed Insulin Degludec concentration after single dose		From 0 to 120 hours after dosing	No
Secondary	Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose		From 0-24 hours after dosing	No
Secondary	Terminal half-life for Insulin Degludec		From 0 to 120 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk