A Trial to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles

A Single Centre, Randomised, 3-period Cross-over Trial to Investigate Different Needle Features Assessed by Comparing Insulin Aspart Pharmacokinetic Profiles

This trial is conducted in Europe. The aim of the trial is to investigate different needle features assessed by comparing insulin aspart Pharmacokinetics profiles (the exposure of the trial drug in the body)

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: insulin aspart

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Male, age at least 18 years at 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 (BMI) 28-39.9 kg/m^2 (overweight to obese)
• Caucasian

Exclusion Criteria:

• Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
• Non-fasting blood glucose test with blood glucose values above 11.1 millimol per liter (mmol/L)
• HbA1c (Glycosylated Haemoglobin) equal to or above 6.5%
• Known active or in-active skin disease in the injection area or that could affect pain perception
• History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator
• Use of any prescription or non-prescription medication, including herbal products and nonroutine vitamins, within the last 2 weeks before screening
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period
• Known or suspected abuse of alcohol (defined as regular intake of more than 14 units weekly for men where 1 unit equals 300 milliliter (mL) of beer, 100 mL of wine, or 25 mL of distilled spirits)
• Positive result of an alcohol breath test
• Known or suspected drug/chemical substance abuse within 1 year from screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 mm needle	Drug: insulin aspart; All subjects make three intervention visits with at least 5 days between individual intervention visits. At each intervention visit the subject receives one insulin aspart injection with only one type of needle.
Experimental: 3.5 mm needle	Drug: insulin aspart; All subjects make three intervention visits with at least 5 days between individual intervention visits. At each intervention visit the subject receives one insulin aspart injection with only one type of needle.
Active Comparator: 4 mm needle	Drug: insulin aspart; All subjects make three intervention visits with at least 5 days between individual intervention visits. At each intervention visit the subject receives one insulin aspart injection with only one type of needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under curve insulin aspart measured in serum	During a maximum of 8 hours
Maximum concentration of insulin aspart measured in serum	During a maximum of 8 hours

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2015
• Primary Completion (Actual): January 28, 2016
• Study Completion (Actual): January 28, 2016

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart
• Other Study ID Numbers: INS-4219; U1111-1164-2873 (Other Identifier: WHO)