Comparison of Two Formulations of Biphasic Insulin Aspart 70

February 22, 2017 updated by: Novo Nordisk A/S

A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom, LS2 9NG
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIAsp 70 clinical trial formulation
Drug: biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin)
Experimental: BIAsp 70 final formulation
Drug: biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin)
Experimental: BIAsp 50 final formulation
Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the insulin aspart curve in the interval from 0-24 hours

Secondary Outcome Measures

Outcome Measure
t½, terminal half-life
Cmax, maximum insulin aspart concentration
tmax, the time to maximum insulin aspart concentration
Cmin, minimum glucose concentration
tmin, time to minimum concentration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 1999

Primary Completion (Actual)

November 30, 1999

Study Completion (Actual)

November 30, 1999

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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