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

NCT02089451 | Completed Phase 1

• 3 other identifiers: NN1218-39492011-002590-32U1111-1121-8351
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)

  From 0 to 12 hours

Secondary Outcomes (2)

• 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

Study Arms (1)

FIAsp

EXPERIMENTAL

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

Drug: Faster-acting insulin aspart

Interventions

Faster-acting insulin aspart 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)

FIAsp

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

• 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.

  PMID: 28185141 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: March 17, 2014
• Study Start: March 17, 2014
• Primary Completion: June 6, 2014
• Study Completion: June 6, 2014
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

DE (1)