Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects

January 14, 2016 updated by: Novo Nordisk A/S

A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects

This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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

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:

  • Japanese passport holder
  • Japanese-born parents
  • Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • Fasting blood glucose of below or equal to 6 mmol/L
  • Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator

Exclusion Criteria:

  • The receipt of any investigational drug within 3 months prior to this trial
  • Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, as judged by the Investigator

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose, insulin degludec
Drug: placebo
Administered subcutaneously (s.c., under the skin)
Drug: insulin degludec
Single dose administered subcutaneously (s.c., under the skin).
Experimental: Medium dose, insulin degludec
Drug: placebo
Administered subcutaneously (s.c., under the skin)
Drug: insulin degludec
Single dose administered subcutaneously (s.c., under the skin).
Experimental: High dose, insulin degludec
Drug: placebo
Administered subcutaneously (s.c., under the skin)
Drug: insulin degludec
Single dose administered subcutaneously (s.c., under the skin).
Experimental: IDegAsp 50
Drug: placebo
Administered subcutaneously (s.c., under the skin)
Drug: insulin degludec/insulin aspart 50
Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of adverse events (AEs)
Time Frame: From dosing visit and until follow-up 7-21 days after last dosing visit
From dosing visit and until follow-up 7-21 days after last dosing visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the glucose infusion rate curve
Time Frame: 0-24 hours after dosing
0-24 hours after dosing
Area under the serum insulin concentration curve
Time Frame: 0-96 hours after dosing
0-96 hours after dosing

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

December 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

May 27, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-1788
  • 2006-002615-26 (EudraCT Number)

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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