Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Healthy

Eligibility:

MALE

18-55 years

Phase:

PHASE1

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2007

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT01865331

Start Date

December 1 2006

End Date

March 1 2007

Last Update

January 15 2016

Active Locations (1)

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1

Neuss, Germany, 41460