Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

February 2, 2012
February 2, 2012
November 2002
December 2002   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Healthy
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 A
    Intervention: Drug: biphasic insulin aspart 50
  • Experimental: Formulation B
    Intervention: Drug: biphasic insulin aspart 50
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2002
December 2002   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01527552
BIASP-1488
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Tanja Erichsen Novo Nordisk A/S
Novo Nordisk A/S
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP