A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

Healthy Clinical Trial

Official title:

A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623375
• Other study ID #: NN1250-4000
• Secondary ID: 2012-000078-50U1
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2012
• Last updated: February 18, 2015
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: February 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• 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, analysis of laboratory safety variables, 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-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin degludec
A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).
• insulin degludec
A single dose of 0.04 U/kg body weight will be administered intravenously (i.v., into the vein).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin degludec concentration-of s.c. administration		From 0 to infinity after single dose	No
Primary	Area under the serum insulin degludec concentration-of i.v. administration		From 0 to infinity after single dose	No
Secondary	Terminal half-life for insulin degludec		From 0 to 30 hours after single dose	No
Secondary	Volume of distribution of insulin degludec, estimated during the terminal phase		From 0 to 30 hours after single dose	No

External Links

•   Clinical Trials at Novo Nordisk