Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Subjects

Single-Centre, Randomised, Balanced, Double- Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 50 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01527643

Enrollment

Registered

2012-02-07

Start date

2003-11-11

Completion date

2003-12-17

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 Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.

Interventions

DRUGbiphasic insulin aspart 50

A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits

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 19.0-30.0 kg/m\^2 * Glycohemoglobin (HbA1c) within laboratory normal range * Non-smokers

Exclusion criteria

* The receipt of any investigational drug within the last 3 months prior to this trial. * Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator * Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory * History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen) * HIV (human immunodeficiency virus), Hepatitis B or C positive * Subjects with a first-degree relative with diabetes mellitus * A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions

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
Mean residence time (MRT)	—
tmax, time to maximum insulin aspart concentration	—
Incidence of hypoglycaemic events	—
t½, terminal half-life	—
Area under the insulin aspart curve	—

Countries

Germany

Outcome results

None listed

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