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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02594033

Collaborator

(none)

Enrollment

Location

Arms

3.1

Actual Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: insulin aspart	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 27, 2015

Actual Primary Completion Date :

Jan 28, 2016

Actual Study Completion Date :

Jan 28, 2016

Arms and Interventions

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.

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

Active Comparator: 4 mm needle

Drug: insulin aspart

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Neuss		Germany	41460

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT02594033

Other Study ID Numbers:

INS-4219
U1111-1164-2873

First Posted:

Nov 1, 2015

Last Update Posted:

Aug 1, 2017

Last Verified:

Jul 1, 2017

Additional relevant MeSH terms:

Insulin Aspart

Study Results

No Results Posted as of Aug 1, 2017