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

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.
 
ClinicalTrials.gov Identifier: NCT01527552
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE February 2, 2012
First Posted Date  ICMJE February 7, 2012
Last Update Posted Date February 24, 2017
Actual Study Start Date  ICMJE November 5, 2002
Actual Primary Completion Date December 18, 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
  • Area under the insulin aspart curve in the interval from 0-16 hours
  • Cmax, maximum insulin aspart concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01527552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
  • tmax, the time to maximum insulin aspart concentration
  • Area under the insulin aspart curve
  • Mean residence time (MRT)
  • The area under the glucose infusion rate curve
  • GIRmax, maximum glucose infusion rate value
  • tGIRmax, time to maximum glucose infusion rate value
  • Adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Healthy
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Formulation A
    Intervention: Drug: biphasic insulin aspart 50
  • Experimental: Formulation B
    Intervention: Drug: biphasic insulin aspart 50
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2012)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 18, 2002
Actual Primary Completion Date December 18, 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01527552
Other Study ID Numbers  ICMJE BIASP-1488
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

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