A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects

Healthy Clinical Trial

Official title:

A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151072
• Other study ID #: NN1250-1992
• Secondary ID: 2009-017217-30U1
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2010
• Last updated: January 19, 2017
• Start date: June 2010
• Est. completion date: October 2010

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial was conducted in Europe. The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin degludec
Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Nosek L, Coester HV, Roepstorff C, Thomsen HF, Kristensen NR, Haahr H, Heise T. Glucose-lowering effect of insulin degludec is independent of subcutaneous injection region. Clin Drug Investig. 2014 Sep;34(9):673-9. doi: 10.1007/s40261-014-0218-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration)		From 0 to 120 hours after single-dose
Secondary	Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration)		From 0 to 120 hours after single-dose
Secondary	Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration)		From 0 to 30 hours after single-dose
Secondary	Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration)		Within 0 to 120 hours after dosing
Secondary	Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration)		At time zero after dosing

External Links

•   Clinical Trials at Novo Nordisk