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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486914
First Posted: December 7, 2011
Last Update Posted: March 1, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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
Diabetes Healthy Drug: insulin aspart Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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)

Secondary Outcome Measures:
  • Cmax (maximum plasma concentration)
  • Terminal half life (t½)
  • Incident of hypoglycaemic episodes
  • Adverse events

Enrollment: 28
Actual Study Start Date: January 19, 2003
Study Completion Date: February 24, 2003
Primary Completion Date: February 24, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486914


Locations
United Kingdom
Novo Nordisk Investigational Site
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01486914     History of Changes
Other Study ID Numbers: NN2000-1512
First Submitted: December 5, 2011
First Posted: December 7, 2011
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs