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Completed

NCT Number: NCT01865331

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

Single dose administered subcutaneously (s.c., under the skin).

Placebo

Drug

Administered subcutaneously (s.c., under the skin)

insulin degludec/insulin aspart 50

Drug

Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)

Primary outcomes

  1. Frequency of adverse events (AEs)

    Time frame: From dosing visit and until follow-up 7-21 days after last dosing visit

Secondary outcomes

  1. Area under the serum insulin concentration curve

    Time frame: 0-96 hours after dosing

  2. Area under the glucose infusion rate curve

    Time frame: 0-24 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 30, 2013
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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