A Comparison Between Two Formulations of NN5401 in Healthy Subjects

NCT ID: NCT01125553

Last Updated: 2015-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-08-31

Brief Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.

Conditions

Diabetes; Healthy

Study Design

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

Study Groups

IDegAsp B

Group Type: EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type: DRUG

Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).

IDegAsp F

Group Type: EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type: DRUG

Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).

Interventions

insulin degludec/insulin aspart

Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the physician
• Body mass index between 18.0 and 27.0 kg/m^2 (both inclusive)

Exclusion Criteria

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

• 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 Clinical Trial Call Center

Chula Vista, California, United States

Countries

United States

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1113-7011

Identifier Type: OTHER

Identifier Source: secondary_id

NN5401-1980

Identifier Type: -

Identifier Source: org_study_id