Effect of NN5401 in Japanese Subjects With Type 1 Diabetes
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese Subjects With Type 1 Diabetes
2 other identifiers
interventional
21
1 country
1
Brief Summary
This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Jan 2010
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
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 15, 2010
CompletedFirst Posted
Study publicly available on registry
January 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 10, 2017
February 1, 2017
3 months
January 15, 2010
February 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the Glucose Infusion Rate curve after a single dose
From 4-12 hours
Secondary Outcomes (1)
Area under the insulin aspart concentration-time curve after a single dose
From 0-12 hours
Study Arms (2)
IDegAsp
EXPERIMENTALBIAsp 30
ACTIVE COMPARATORInterventions
Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
Eligibility Criteria
You may qualify if:
- Japanese subject
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index (BMI): 18.0-28.0 kg/m\^2 (both inclusive)
You may not qualify if:
- Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) or the equivalent per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Tokyo, 130-0004, Japan
Related Publications (1)
Ikushima I, Hirao K, Sasaki T, Fumiaki K, Clauson P, Roepstorff C, Haahr HL. Glucose lowering effect of IDegAsp in Japanese subjects with type 1 diabetes. 56th Annual Meeting of the Japan Diabetes Society (JDS) 2013; Country: Japan City: Kumamoto
RESULT
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
January 15, 2010
First Posted
January 18, 2010
Study Start
January 1, 2010
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 10, 2017
Record last verified: 2017-02