Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01620450
First received: June 13, 2012
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Diabetes
Healthy
Drug: biphasic human insulin 30
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, Randomised, Double Blind, Cross-over Trial Demonstrating the Bioequivalence Between NN2000-Mix30 and NN-X14Mix30 (NovoRapid® 30 Mix) in Healthy Japanese Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h) [ Time Frame: From 0 to 16 hours after injection ] [ Designated as safety issue: No ]
  • Maximum insulin aspart concentration (Cmax IAsp) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve of insulin aspart concentration (AUC IAsp) [ Designated as safety issue: No ]
  • Time to maximum insulin aspart concentration (tmax IAsp) [ Designated as safety issue: No ]
  • Terminal elimination half life (t½) [ Designated as safety issue: No ]
  • Body weight [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: November 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NN2000 Drug: biphasic human insulin 30
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
Active Comparator: NN-X14 Drug: biphasic human insulin 30
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese
  • Considered generally healthy based on medical history and physical examination
  • Body Mass Index (BMI) between 18 and 27 kg/m^2 (both inclusive)
  • Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)

Exclusion Criteria:

  • Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis
  • Any serious systemic infectious disease that occurred during the last 4 weeks before trial
  • Any inter-current illness that may affect blood glucose
  • Subject with a first degree relative with diabetes mellitus
  • Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620450

Locations
Japan
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Hiromasa Ono Novo Nordisk Pharma Ltd.
Study Director: Yasuhiro Honda Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01620450     History of Changes
Other Study ID Numbers: NN2000-1612
Study First Received: June 13, 2012
Last Updated: November 21, 2013
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

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

ClinicalTrials.gov processed this record on April 17, 2014