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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: biphasic insulin aspart 70

Study type

Interventional

Funder types

Industry

Identifiers

NCT01527656

BIASP-1577

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

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
A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial 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 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
Known or suspected allergy to trial product or related products
Smoking during the past three months