- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934712
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
December 7, 2018 updated by: Novo Nordisk A/S
This trial is conducted in Japan.
The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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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Fukuoka, Japan, 812-0025
- 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 64 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
- Body mass index (BMI) 18.5-28.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- Not able or willing to refrain from smoking and use of nicotine substitute products 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: FIAsp
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
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Single dose injected subcutaneously (s.c, under the skin)
Single dose injected subcutaneously (s.c, under the skin)
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Active Comparator: NovoRapid®
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
|
Single dose injected subcutaneously (s.c, under the skin)
Single dose injected subcutaneously (s.c, under the skin)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0-1 hour
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From 0-1 hour
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0-12 hours
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From 0-12 hours
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Area under the glucose infusion rate (GIR) curve
Time Frame: From 0-1 hour
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From 0-1 hour
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Area under the glucose infusion rate (GIR) curve
Time Frame: From 0-12 hours
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From 0-12 hours
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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
- Shiramoto M, Nishida T, Hansen AK, Haahr H. Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart. J Diabetes Investig. 2018 Mar;9(2):303-310. doi: 10.1111/jdi.12697. Epub 2017 Jul 7.
- Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
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 (Actual)
August 30, 2013
Primary Completion (Actual)
January 28, 2014
Study Completion (Actual)
January 28, 2014
Study Registration Dates
First Submitted
August 30, 2013
First Submitted That Met QC Criteria
August 30, 2013
First Posted (Estimate)
September 4, 2013
Study Record Updates
Last Update Posted (Actual)
December 11, 2018
Last Update Submitted That Met QC Criteria
December 7, 2018
Last Verified
December 1, 2018
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
Other Study ID Numbers
- NN1218-3918
- U1111-1121-2896 (Other Identifier: WHO)
- JapicCTI-132253 (Registry Identifier: JAPIC)
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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