- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02035371
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes
March 8, 2017 updated by: Novo Nordisk A/S
This trial is conducted in Europe.
The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of FIAsp (faster-acting insulin aspart) in children, adolescents and adults with type 1 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
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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Hannover, Germany, 30173
- 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
6 years to 64 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 kg/m^2
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FIAsp
Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days
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A single dose will be administered subcutaneously (s.c.
under the skin)
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Active Comparator: NovoRapid®
Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days
|
A single dose will be administered subcutaneously (s.c.
under the skin)
|
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 to 12 hours
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From 0 to 12 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed serum insulin aspart concentration
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
- Danne T, Biester T, Fath M, Thorsson L, Rikte T, Kordonouri O, Haahr H. Earlier onset and higher early exposure of faster-acting insulin aspart vs. insulin aspart in adults is retained in children and adolescents with T1D. Diabetes 2015; 64 (Suppl. 1): A247 (976-P)
- Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374
- Fath M, Danne T, Biester T, Erichsen L, Kordonouri O, Haahr H. Faster-acting insulin aspart provides faster onset and greater early exposure vs insulin aspart in children and adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2017 Dec;18(8):903-910. doi: 10.1111/pedi.12506. Epub 2017 Feb 6.
- Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559. doi: 10.1007/s40262-017-0514-8.
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)
January 13, 2014
Primary Completion (Actual)
July 24, 2014
Study Completion (Actual)
July 24, 2014
Study Registration Dates
First Submitted
January 10, 2014
First Submitted That Met QC Criteria
January 10, 2014
First Posted (Estimate)
January 14, 2014
Study Record Updates
Last Update Posted (Actual)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 8, 2017
Last Verified
March 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
Other Study ID Numbers
- NN1218-3888
- 2011-002104-32 (EudraCT Number)
- U1111-1121-1469 (Other Identifier: WHO)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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Novo Nordisk A/SCompletedDiabetes Mellitus, Type 1Germany
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1United States, Germany
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany, United States, India, Israel, Italy, Russian Federation, Japan, Finland, Serbia, Turkey, Bulgaria, Estonia, Czechia, Lithuania, Ukraine, Poland, Latvia, Puerto Rico
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Austria
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Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
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Novo Nordisk A/SCompleted