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

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: NCT01486914
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE December 5, 2011
First Posted Date  ICMJE December 7, 2011
Last Update Posted Date March 1, 2017
Actual Study Start Date  ICMJE January 19, 2003
Actual Primary Completion Date February 24, 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
Area under the Curve (AUC) (insulin aspart)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01486914 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
  • Cmax (maximum plasma concentration)
  • Terminal half life (t½)
  • Incident of hypoglycaemic episodes
  • 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
Official Title  ICMJE 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
Brief Summary This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.
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: insulin aspart
Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits
Study Arms  ICMJE
  • Experimental: NN2000
    Intervention: Drug: insulin aspart
  • Active Comparator: IAsp
    Intervention: Drug: insulin aspart
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: December 5, 2011)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 24, 2003
Actual Primary Completion Date February 24, 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01486914
Other Study ID Numbers  ICMJE NN2000-1512
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