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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted

This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.

Condition Intervention Phase
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the Curve (AUC) (insulin aspart) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: January 2003
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN2000 Drug: insulin aspart
Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits
Active Comparator: IAsp Drug: insulin aspart
Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01486914

United Kingdom
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Karsten Lindhardt Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01486914     History of Changes
Other Study ID Numbers: NN2000-1512
Study First Received: December 5, 2011
Last Updated: December 5, 2011
Health Authority: United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)

Additional relevant MeSH terms:
Insulin aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014