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

NCT ID: NCT01530048

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-05-31

Brief Summary

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

U200

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between

U100

Group Type: ACTIVE_COMPARATOR

insulin aspart

Intervention Type: DRUG

A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between

Interventions

insulin aspart

A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

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

Hvidovre, , Denmark

Countries

Denmark

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2005-005538-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PDS290-1750

Identifier Type: -

Identifier Source: org_study_id