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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01448070
First received: October 5, 2011
Last updated: October 7, 2011
Last verified: October 2011
  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
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 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) [ Designated as safety issue: No ]
  • Cmax (maximum plasma concentration) [ Designated as safety issue: No ]
  • Area under the curve (glucose infusion rate (GIR)), 0-8h [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tmax (time to reach maximum) [ Designated as safety issue: No ]
  • t½ (terminal half-life) [ Designated as safety issue: No ]
  • GIR (glucose infusion rate) max [ Designated as safety issue: No ]
  • tGIR (glucose infusion rate) max [ Designated as safety issue: No ]
  • Area under the curve (C-peptide, 0-8h) [ Designated as safety issue: No ]
  • Physical examinations and vital signs [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2002
Study Completion Date: January 2003
Primary Completion Date: January 2003 (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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448070

Locations
United Kingdom
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Birgitte Bentz Damholt Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01448070     History of Changes
Other Study ID Numbers: NN729-1511
Study First Received: October 5, 2011
Last Updated: October 7, 2011
Health Authority: United Kingdom: Medicines And Healthcare Products Regulatory (MHRA)

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

ClinicalTrials.gov processed this record on September 18, 2014