Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

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

A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Non-smokers
  • BMI (body mass index) maximum 27 kg/m^2
  • HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
  • FBG (fasting blood glucose) maximum 6.0 mmol/L

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: Treatment period 1
Drug: biphasic insulin aspart 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
Drug: biphasic human insulin 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
ACTIVE_COMPARATOR: Treatment period 2
Drug: biphasic insulin aspart 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
Drug: biphasic human insulin 30
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the Curve

Secondary Outcome Measures

Outcome Measure
Adverse events
Maximum insulin concentration (Cmax)
Time to maximum insulin concentration (tmax)
Minimum glucose concentration (Cmin(glu))
Time to minimum glucose concentration (tmin(glu))

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

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

November 1, 1995

Primary Completion (ACTUAL)

December 1, 1995

Study Completion (ACTUAL)

December 1, 1995

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (ESTIMATE)

October 16, 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

  • ANA/DCD/031

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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