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
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014