- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01051102
Effect of NN5401 in Japanese Subjects With Type 1 Diabetes
February 9, 2017 updated by: Novo Nordisk A/S
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese Subjects With Type 1 Diabetes
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tokyo, Japan, 130-0004
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IDegAsp
|
Single dose of 0.5 U/kg body weight injected s.c.
(under the skin)
|
ACTIVE_COMPARATOR: BIAsp 30
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Single dose of 0.5 U/kg body weight injected s.c.
(under the skin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the Glucose Infusion Rate curve after a single dose
Time Frame: From 4-12 hours
|
From 4-12 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the insulin aspart concentration-time curve after a single dose
Time Frame: From 0-12 hours
|
From 0-12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
April 1, 2010
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
January 15, 2010
First Submitted That Met QC Criteria
January 15, 2010
First Posted (ESTIMATE)
January 18, 2010
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2017
Last Update Submitted That Met QC Criteria
February 9, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
- Biphasic Insulins
- Insulin aspart, insulin aspart protamine drug combination 30:70
Other Study ID Numbers
- NN5401-1983
- U1111-1112-3698 (OTHER: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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