Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT01530048

2005-005538-11 (EudraCT Number)

PDS290-1750

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.

Enrollment

34 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
Body mass index between 18 and 27 kg/m^2 (both inclusive)
Non-smoker
Fasting blood glucose maximum 6 mmol/L
HbA1c below 6.4%

Exclusion criteria

Pregnant or breast-feeding women
Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
Clinically significant abnormal laboratory values (as judged by the Investigator)
Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
Intake of alcohol within the last 24 hours prior to screening and drug administration visits
Blood donation or blood loss of more than 500 mL within the 3 last months before screening
Strenuous exercise within 48 hours before screening as well as drug administration and followup
Smoking during the past month before drug administration