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Completed

NCT Number: NCT01934712

A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes

This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
  • Body mass index (BMI) 18.5-28.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Treatment and study plan

Faster-acting insulin aspart

Drug

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

insulin aspart

Drug

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

Primary outcomes

  1. Area under the serum insulin aspart concentration-time curve

    Time frame: From 0-1 hour

Secondary outcomes

  1. Area under the serum insulin aspart concentration-time curve

    Time frame: From 0-12 hours

  2. Area under the glucose infusion rate (GIR) curve

    Time frame: From 0-1 hour

  3. Area under the glucose infusion rate (GIR) curve

    Time frame: From 0-12 hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2013
Registry last updated
Dec 11, 2018

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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