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Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01486914
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted

December 5, 2011
December 5, 2011
January 2003
February 2003   (final data collection date for primary outcome measure)
Area under the Curve (AUC) (insulin aspart) [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Cmax (maximum plasma concentration) [ Designated as safety issue: No ]
  • Terminal half life (t½) [ Designated as safety issue: No ]
  • Incident of hypoglycaemic episodes [ 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
A Single Centre, Randomized, Balanced Double Blind, Cross-Over Trial Investigating the Bioequivalence of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process

This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.
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: insulin aspart
Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits
  • Experimental: NN2000
    Intervention: Drug: insulin aspart
  • Active Comparator: IAsp
    Intervention: Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2003
February 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy
  • Caucasian
  • Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
  • Fasting blood glucose below or equal to 6 mmol/L
  • Body mass index (BMI) 22.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Participated in another clinical study with an investigational drug within the last 4 weeks
  • Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
  • Known or suspected allergy to the trial product or related products
  • Family history of type 2 diabetes
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01486914
NN2000-1512
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Karsten Lindhardt Novo Nordisk
Novo Nordisk
December 2011

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