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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594033
• Other study ID #: INS-4219
• Secondary ID: U1111-1164-2873
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2015
• Last updated: July 31, 2017
• Start date: October 27, 2015
• Est. completion date: January 28, 2016

Study information

• Verified date: July 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 28, 2016
• Est. primary completion date: January 28, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve insulin aspart measured in serum		During a maximum of 8 hours
Primary	Maximum concentration of insulin aspart measured in serum		During a maximum of 8 hours

External Links

•   Clinical Trials at Novo Nordisk