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Completed

NCT Number: NCT01527552

Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects

This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 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–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Bloemfontein, 9324, South Africa

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
  • Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
  • Minimum body weight of 65 kg
  • Fasting blood glucose between 3.8-6.0 mmol/L
  • Glycohemoglobin (HbA1c) below 6.4 %
  • Non-smokers

Exclusion criteria

  • Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
  • A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
  • History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
  • Hepatitis B or C
  • Subjects with a first-degree relative with diabetes mellitus
  • Known or suspected allergy to trial product or related products
  • Smoking during the past three months

Treatment and study plan

biphasic insulin aspart 50

Drug

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days

Primary outcomes

  1. Area under the insulin aspart curve in the interval from 0-16 hours

  2. Cmax, maximum insulin aspart concentration

Secondary outcomes

  1. tmax, the time to maximum insulin aspart concentration

  2. Area under the insulin aspart curve

  3. Mean residence time (MRT)

  4. The area under the glucose infusion rate curve

  5. GIRmax, maximum glucose infusion rate value

  6. tGIRmax, time to maximum glucose infusion rate value

  7. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Feb 7, 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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