Comparison of Two Formulations of Biphasic Insulin Aspart 70

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: biphasic insulin aspart 70; Drug: biphasic insulin aspart 50

• Registration Number: NCT01523041
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.

Detailed Description

Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

Study Timeline

• Study Start: 1999-11-03
• Primary Completion: 1999-11-30
• Study Completion: 1999-11-30
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Caucasian
• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body mass index (BMI) between 19-27 kg/m^2
• Fasting plasma glucose between 3.8-6.0 mmol/L

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Exclusion Criteria

• Participation in any other clinical trial involving other investigational products within the last three months
• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
• Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIAsp 70 clinical trial formulation	biphasic insulin aspart 70	-
BIAsp 70 final formulation	biphasic insulin aspart 70	-
BIAsp 50 final formulation	biphasic insulin aspart 50	-

Primary Outcome Measures

Name	Time	Method
Area under the insulin aspart curve in the interval from 0-24 hours

Secondary Outcome Measures

Name	Time	Method
t½, terminal half-life
Cmin, minimum glucose concentration
tmin, time to minimum concentration
Cmax, maximum insulin aspart concentration
tmax, the time to maximum insulin aspart concentration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Leeds, United Kingdom