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Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448070
First Posted: October 7, 2011
Last Update Posted: February 27, 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 show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.

Condition Intervention Phase
Diabetes Healthy Drug: human insulin 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 Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process

Resource links provided by NLM:


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

Primary Outcome Measures:
  • AUC (area under the curve) 0-8h (human insulin)
  • Cmax (maximum plasma concentration)
  • Area under the curve (glucose infusion rate (GIR)), 0-8h

Secondary Outcome Measures:
  • tmax (time to reach maximum)
  • t½ (terminal half-life)
  • GIR (glucose infusion rate) max
  • tGIR (glucose infusion rate) max
  • Area under the curve (C-peptide, 0-8h)
  • Physical examinations and vital signs

Enrollment: 28
Actual Study Start Date: October 15, 2002
Study Completion Date: December 20, 2002
Primary Completion Date: December 20, 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN729 manufacturing process Drug: human insulin
Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)
Active Comparator: Current manufacturing process Drug: human insulin
Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)

  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:   Yes
Criteria

Inclusion Criteria:

  • 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 1 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): NCT01448070


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: NCT01448070     History of Changes
Other Study ID Numbers: NN729-1511
First Submitted: October 5, 2011
First Posted: October 7, 2011
Last Update Posted: February 27, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs