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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01527565

Enrollment

Registered

2012-02-07

Start date

2003-01-20

Completion date

2003-02-26

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGbiphasic 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the insulin aspart curve in the interval from 0-16 hours	—
Cmax, maximum insulin aspart concentration	—

Secondary

Measure	Time frame
tmax, the time to maximum insulin aspart concentration	—
Area under the insulin aspart curve	—
Mean residence time (MRT)	—
The area under the glucose infusion rate curve	—
GIRmax, maximum glucose infusion rate value	—
tGIRmax, time to maximum glucose infusion rate value	—
Adverse events	—

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026