Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese
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
1 other identifier
interventional
34
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes
Started Nov 2004
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 20, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2005
CompletedFirst Submitted
Initial submission to the registry
June 13, 2012
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedMarch 1, 2017
February 1, 2017
3 months
June 13, 2012
February 28, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h)
From 0 to 16 hours after injection
Maximum insulin aspart concentration (Cmax IAsp)
Secondary Outcomes (5)
Area under the curve of insulin aspart concentration (AUC IAsp)
Time to maximum insulin aspart concentration (tmax IAsp)
Terminal elimination half life (t½)
Body weight
Adverse events
Study Arms (2)
NN2000
EXPERIMENTALNN-X14
ACTIVE COMPARATORInterventions
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Tokyo, 1000005, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2012
First Posted
June 15, 2012
Study Start
November 20, 2004
Primary Completion
February 26, 2005
Study Completion
February 26, 2005
Last Updated
March 1, 2017
Record last verified: 2017-02