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

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

A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • South Africa
      • Bloemfontein, South Africa, 9324
        • 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 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Considered generally healthy upon completion of medical history and physical
  • examination, as judged by the investigator
  • Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
  • Minimum body weight of 65 kg
  • Fasting blood glucose between 3.8-6.0 mmol/L
  • Glycohemoglobin (HbA1c) below 6.4 %
  • Non-smokers

Exclusion Criteria:

  • Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
  • A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study 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 drug/alcohol abuse screen)
  • Hepatitis B or C
  • Subjects with a first-degree relative with diabetes mellitus
  • Known or suspected allergy to trial product or related products
  • Smoking during the past three months

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Formulation A
Drug: biphasic insulin aspart 70
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
EXPERIMENTAL: Formulation B
Drug: biphasic insulin aspart 70
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration

Secondary Outcome Measures

Outcome Measure
Mean residence time (MRT)
Adverse events
tmax, the time to maximum insulin aspart concentration
Area under the insulin aspart curve
The area under the glucose infusion rate curve
GIRmax, maximum glucose infusion rate value
tGIRmax, time to maximum glucose infusion rate value

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)

January 20, 2003

Primary Completion (ACTUAL)

February 26, 2003

Study Completion (ACTUAL)

February 26, 2003

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (ESTIMATE)

February 7, 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-1489

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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