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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01527656
First Posted: February 7, 2012
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Healthy Drug: biphasic insulin aspart 70 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the insulin aspart curve in the interval from 0-16 hours
  • Cmax, maximum insulin aspart concentration

Secondary Outcome Measures:
  • tmax, time to maximum insulin aspart concentration
  • Area under the insulin aspart curve
  • Mean residence time (MRT)
  • t½, terminal half-life
  • Incidence of hypoglycaemic events

Enrollment: 40
Study Start Date: December 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A Drug: biphasic insulin aspart 70
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
Experimental: Formulation B Drug: biphasic insulin aspart 70
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527656


Locations
Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01527656     History of Changes
Other Study ID Numbers: BIASP-1577
First Submitted: February 2, 2012
First Posted: February 7, 2012
Last Update Posted: January 6, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs