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

NCT ID: NCT02594033

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-27
• Study Completion Date: 2016-01-28

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)

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

3 mm needle

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

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.

3.5 mm needle

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

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.

4 mm needle

Group Type: ACTIVE_COMPARATOR

insulin aspart

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

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

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1164-2873

Identifier Type: OTHER

Identifier Source: secondary_id

INS-4219

Identifier Type: -

Identifier Source: org_study_id