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Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

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: NCT01620450
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE June 13, 2012
First Posted Date  ICMJE June 15, 2012
Last Update Posted Date March 1, 2017
Actual Study Start Date  ICMJE November 20, 2004
Actual Primary Completion Date February 26, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h) [ Time Frame: From 0 to 16 hours after injection ]
  • Maximum insulin aspart concentration (Cmax IAsp)
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
  • Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)
  • Maximum insulin aspart concentration (Cmax IAsp)
Change History Complete list of historical versions of study NCT01620450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
  • Area under the curve of insulin aspart concentration (AUC IAsp)
  • Time to maximum insulin aspart concentration (tmax IAsp)
  • Terminal elimination half life (t½)
  • Body weight
  • 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 Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
Official Title  ICMJE A Single-centre, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects
Brief Summary This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese 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 human insulin 30
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
Study Arms  ICMJE
  • Experimental: NN2000
    Intervention: Drug: biphasic human insulin 30
  • Active Comparator: NN-X14
    Intervention: Drug: biphasic human insulin 30
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: June 13, 2012)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 26, 2005
Actual Primary Completion Date February 26, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese
  • Considered generally healthy based on medical history and physical examination
  • Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
  • Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria:

  • Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
  • Any serious systemic infectious disease that occurred during the last 4 weeks before trial
  • Any inter-current illness that may affect blood glucose
  • Subject with a first degree relative with diabetes mellitus
  • Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620450
Other Study ID Numbers  ICMJE NN2000-1612
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