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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Treatments

Drug: insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT02594033

INS-4219

U1111-1164-2873 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment

46 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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