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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: Faster-acting insulin aspart

• Registration Number: NCT02089451
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-03-14
• Study Start: 2014-03-17
• Study First Posted: 2014-03-17
• Primary Completion: 2014-06-06
• Study Completion: 2014-06-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FIAsp	Faster-acting insulin aspart	Each subject will be randomised to a treatment sequence consisting of 5 treatment periods

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)	From 0 to 12 hours

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve (only for intramuscular administration)	From 0 to 12 hours
Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration)	From 0 to 12 hours

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany