Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects

October 21, 2015 updated by: Novo Nordisk A/S

A Randomised, Double-blind, Single Centre, Placebocontrolled, Parallel Group, Multiple s.c. Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Two SIAC Preparations and Two Insulin 454 (SIBA) Preparations in Healthy Japanese Male Subjects

This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp) preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar to the proposed commercial formulations.

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

  • Japan
      • Tokyo, Japan, 1000005

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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy Japanese male subjects
  • Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • Body weight above or equal to 50 kg

Exclusion Criteria:

  • The receipt of any investigational drug within 16 weeks prior to this trial (the planned first dosing)
  • Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the investigator or sub-investigator
  • Known or suspected allergy to trial product(s) or related products

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: IDegAsp 30
Drug: insulin degludec/insulin aspart 30
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Drug: placebo
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Experimental: IDegAsp 45
Drug: placebo
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Drug: insulin degludec/insulin aspart 45
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Experimental: insulin degludec (B)
Drug: placebo
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Drug: insulin degludec
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Experimental: insulin degludec (E)
Drug: placebo
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
Drug: insulin degludec
Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: Day 1-6 and 7-28 days after day 6
Day 1-6 and 7-28 days after day 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin 454 concentration curve
Time Frame: 0-96 hours after last dosing
0-96 hours after last dosing
Area under the serum insulin aspart concentration curve
Time Frame: 0-6 hours after dosing
0-6 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, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-1790

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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