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

Phase 1

Completed

• Conditions: Healthy; Diabetes
• Interventions: Drug: biphasic insulin aspart 50

• Registration Number: NCT01527643
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11-11
• Primary Completion: 2003-12-17
• Study Completion: 2003-12-17
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation A	biphasic insulin aspart 50	-
Formulation B	biphasic insulin aspart 50	-

Primary Outcome Measures

Name	Time	Method
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany