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

NCT ID: NCT02089451

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-17
• Study Completion Date: 2014-06-06

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FIAsp

Each subject will be randomised to a treatment sequence consisting of 5 treatment periods

Group Type: EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

References

Hovelmann U, Heise T, Nosek L, Sassenfeld B, Thomsen KMD, Haahr H. Pharmacokinetic Properties of Fast-Acting Insulin Aspart Administered in Different Subcutaneous Injection Regions. Clin Drug Investig. 2017 May;37(5):503-509. doi: 10.1007/s40261-017-0499-y.

Reference Type: RESULT

PMID: 28185141 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2011-002590-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1121-8351

Identifier Type: OTHER

Identifier Source: secondary_id

NN1218-3949

Identifier Type: -

Identifier Source: org_study_id