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Completed

NCT Number: NCT01523041

Comparison of Two Formulations of Biphasic Insulin Aspart 70

This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male 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–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Leeds, LS2 9NG, United Kingdom

About this study

Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Caucasian
  • Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • Body mass index (BMI) between 19-27 kg/m^2
  • Fasting plasma glucose between 3.8-6.0 mmol/L

Exclusion criteria

  • Participation in any other clinical trial involving other investigational products within the last three months
  • Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
  • Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug

Treatment and study plan

biphasic insulin aspart 70

Drug

A single dose administrated subcutaneously (s.c., under the skin)

biphasic insulin aspart 50

Drug

A single dose administrated subcutaneously (s.c., under the skin)

Primary outcomes

  1. Area under the insulin aspart curve in the interval from 0-24 hours

Secondary outcomes

  1. Cmax, maximum insulin aspart concentration

  2. tmax, the time to maximum insulin aspart concentration

  3. t½, terminal half-life

  4. Cmin, minimum glucose concentration

  5. tmin, time to minimum concentration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male Subjects

Important dates

Study start
1999
Primary completion
1999
Study completion
1999
First posted
Feb 1, 2012
Registry last updated
Feb 24, 2017

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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