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Completed

NCT Number: NCT01868555

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

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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

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

insulin degludec

Drug

Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

insulin degludec/insulin aspart 30

Drug

Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

insulin degludec/insulin aspart 45

Drug

Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

Placebo

Drug

Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Day 1-6 and 7-28 days after day 6

Secondary outcomes

  1. Area under the serum insulin 454 concentration curve

    Time frame: 0-96 hours after last dosing

  2. Area under the serum insulin aspart concentration curve

    Time frame: 0-6 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2013
Registry last updated
Oct 22, 2015

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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