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

Healthy Clinical Trial

Official title:

A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527565
• Other study ID #: BIASP-1489
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2012
• Last updated: February 22, 2017
• Start date: January 20, 2003
• Est. completion date: February 26, 2003

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 26, 2003
• Est. primary completion date: February 26, 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
South Africa	Novo Nordisk Investigational Site	Bloemfontein

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin aspart curve in the interval from 0-16 hours
Primary	Cmax, maximum insulin aspart concentration
Secondary	tmax, the time to maximum insulin aspart concentration
Secondary	Area under the insulin aspart curve
Secondary	Mean residence time (MRT)
Secondary	The area under the glucose infusion rate curve
Secondary	GIRmax, maximum glucose infusion rate value
Secondary	tGIRmax, time to maximum glucose infusion rate value
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk