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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01527552
First received: February 2, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
 Drug: biphasic insulin aspart 50
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the insulin aspart curve in the interval from 0-16 hours [ Designated as safety issue: No ]
  • Cmax, maximum insulin aspart concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tmax, the time to maximum insulin aspart concentration [ Designated as safety issue: No ]
  • Area under the insulin aspart curve [ Designated as safety issue: No ]
  • Mean residence time (MRT) [ Designated as safety issue: No ]
  • The area under the glucose infusion rate curve [ Designated as safety issue: No ]
  • GIRmax, maximum glucose infusion rate value [ Designated as safety issue: No ]
  • tGIRmax, time to maximum glucose infusion rate value [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A Drug: biphasic insulin aspart 50
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
Experimental: Formulation B Drug: biphasic insulin aspart 50
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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 19-29 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527552

Locations
South Africa
Bloemfontein, South Africa, 9324
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Tanja Erichsen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01527552     History of Changes
Other Study ID Numbers: BIASP-1488
Study First Received: February 2, 2012
Last Updated: February 2, 2012
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013