Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects

NCT ID: NCT01527565

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-20
• Study Completion Date: 2003-02-26

Brief Summary

This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.

Conditions

Diabetes; Healthy

Study Design

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

Study Groups

Formulation A

Group Type: EXPERIMENTAL

biphasic insulin aspart 70

Intervention Type: DRUG

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days

Formulation B

Group Type: EXPERIMENTAL

biphasic insulin aspart 70

Intervention Type: DRUG

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days

Interventions

biphasic insulin aspart 70

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Considered generally healthy upon completion of medical history and physical
• examination, as judged by the investigator
• Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
• Minimum body weight of 65 kg
• Fasting blood glucose between 3.8-6.0 mmol/L
• Glycohemoglobin (HbA1c) below 6.4 %
• Non-smokers

Exclusion Criteria

• Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
• A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
• History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
• Hepatitis B or C
• Subjects with a first-degree relative with diabetes mellitus
• Known or suspected allergy to trial product or related products
• Smoking during the past three months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• 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

Bloemfontein, , South Africa

Countries

South Africa

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

BIASP-1489

Identifier Type: -

Identifier Source: org_study_id