Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

NCT ID: NCT01620450

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-20
• Study Completion Date: 2005-02-26

Brief Summary

This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.

Conditions

Diabetes; Healthy

Study Design

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

Study Groups

NN2000

Group Type: EXPERIMENTAL

biphasic human insulin 30

Intervention Type: DRUG

Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits

NN-X14

Group Type: ACTIVE_COMPARATOR

biphasic human insulin 30

Intervention Type: DRUG

Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits

Interventions

biphasic human insulin 30

Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Japanese
• Considered generally healthy based on medical history and physical examination
• Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
• Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria

• Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
• Any serious systemic infectious disease that occurred during the last 4 weeks before trial
• Any inter-current illness that may affect blood glucose
• Subject with a first degree relative with diabetes mellitus
• Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

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

Tokyo, , Japan

Countries

Japan

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

NN2000-1612

Identifier Type: -

Identifier Source: org_study_id