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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01620450
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 13, 2012
June 13, 2012
November 2004
February 2005   (final data collection date for primary outcome measure)
  • Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h) [ Designated as safety issue: No ]
  • Maximum insulin aspart concentration (Cmax IAsp) [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Area under the curve of insulin aspart concentration (AUC IAsp) [ Designated as safety issue: No ]
  • Time to maximum insulin aspart concentration (tmax IAsp) [ Designated as safety issue: No ]
  • Terminal elimination half life (t½) [ Designated as safety issue: No ]
  • Body weight [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
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

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.
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 human insulin 30
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
  • Experimental: NN2000
    Intervention: Drug: biphasic human insulin 30
  • Active Comparator: NN-X14
    Intervention: Drug: biphasic human insulin 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
February 2005
February 2005   (final data collection date for primary outcome measure)

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
Male
20 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01620450
NN2000-1612
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Hiromasa Ono Novo Nordisk Pharma Ltd.
Study Director: Yasuhiro Honda Novo Nordisk Pharma Ltd.
Novo Nordisk
June 2012

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