Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

January 3, 2017 updated by: Novo Nordisk A/S

A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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

  • Germany
      • Neuss, Germany, 41460
        • 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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index between 18 and 28 kg/m^2 inclusive
  • HbA1c within the normal laboratory range
  • Non smoker for at least three months
  • Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion Criteria:

  • Subjects who have received any investigational drug in the 3 months prior to the start of dosing
  • Any disease requiring regular use of non topical prescription medicines
  • Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
  • Any intercurrent illness or endocrine disorders that may affect blood glucose
  • Subject with a history of drug or alcohol dependence
  • Subject with a first degree relative with diabetes mellitus
  • Subject with a history of clinically relevant allergic reactions to medical products
  • Subjects who have donated any blood or plasma in the past 3 month preceding screening

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 30
Drug: biphasic insulin aspart 30
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Experimental: BIAsp 50
Drug: biphasic insulin aspart 50
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Experimental: BIAsp 70
Drug: biphasic insulin aspart 70
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Active Comparator: Insulin aspart
Drug: insulin aspart
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes

Secondary Outcome Measures

Outcome Measure
t½, terminal half-life
Cmax, maximum insulin aspart concentration
tmax, the time to maximum insulin aspart concentration
Maximum GIR value
Time to maximum GIR value
Area under the GIR profile
Area under the insulin aspart concentration curve

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.

General Publications

  • Heise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301

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

April 1, 1999

Primary Completion (Actual)

May 1, 2000

Study Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1086

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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