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Completed

NCT Number: NCT01527656

Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of 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–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

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 19.0-30.0 kg/m^2
  • Glycohemoglobin (HbA1c) within laboratory normal range
  • Non-smokers

Exclusion criteria

  • Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
  • Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
  • A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial 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 urine drug screen and breath alcohol screen)
  • HIV (human immunodeficiency virus), Hepatitis B or C positive
  • Subjects with a first-degree relative with diabetes mellitus
  • A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
  • Known or suspected allergy to trial product or related products
  • Smoking during the past three months

Treatment and study plan

biphasic insulin aspart 70

Drug

A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits

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, time to maximum insulin aspart concentration

  2. Area under the insulin aspart curve

  3. Mean residence time (MRT)

  4. t½, terminal half-life

  5. Incidence of hypoglycaemic events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 70 in Healthy Male Subjects

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Feb 7, 2012
Registry last updated
Jan 6, 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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