A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects

Healthy Clinical Trial

Official title:

A Trial Comparing the Pharmacokinetic Properties of FIAsp After Different Injection Regions and Routes of Administration in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089451
• Other study ID #: NN1218-3949
• Secondary ID: 2011-002590-32U1
• Status: Completed
• Phase: Phase 1
• First received: January 30, 2014
• Last updated: February 16, 2017
• Start date: March 17, 2014
• Est. completion date: June 6, 2014

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 the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 6, 2014
• Est. primary completion date: June 6, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18-64 years both inclusive at the time of signing informed consent

• 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 20.0-28.0 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 at least one cigarette, cigar or pipe daily)

• Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• Faster-acting insulin aspart
Drug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein)

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)

Hövelmann U, Heise T, Nosek L, Sassenfeld B, Thomsen KM, Haahr H. Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions. Clin Drug Investig. 2017 Feb 10. doi: 10.1007/s40261-017-0499-y. [Epub ahe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)		From 0 to 12 hours
Secondary	Area under the serum insulin aspart concentration-time curve (only for intramuscular administration)		From 0 to 12 hours
Secondary	Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration)		From 0 to 12 hours

External Links

•   Clinical Trials at Novo Nordisk