- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02033239
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
January 16, 2017 updated by: Novo Nordisk A/S
A Trial Investigating the Pharmacodynamic Response of FIAsp in Subjects With Type 1 Diabetes
This trial is conducted in Europe.
The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
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
-
-
-
Neuss, Germany, 41460
- Novo Nordisk Investigational Site
-
-
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
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female aged 18-64 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 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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FIAsp
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
|
Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®.
Single dose of trial products will be administered subcutaneously (s.c.
under the skin).
|
Active Comparator: NovoRapid®
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
|
Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®.
Single dose of trial products will be administered subcutaneously (s.c.
under the skin).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the glucose infusion rate curve
Time Frame: From 0 to 12 hours
|
From 0 to 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0 to 12 hours
|
From 0 to 12 hours
|
Maximum glucose infusion rate
Time Frame: Within 0 to 12 hours after dosing
|
Within 0 to 12 hours after dosing
|
Maximum observed serum insulin aspart concentration
Time Frame: Within 0 to 12 hours after dosing
|
Within 0 to 12 hours after dosing
|
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
- 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
- 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.
- Heise T, Stender-Petersen K, Hovelmann U, Jacobsen JB, Nosek L, Zijlstra E, Haahr H. Pharmacokinetic and Pharmacodynamic Properties of Faster-Acting Insulin Aspart versus Insulin Aspart Across a Clinically Relevant Dose Range in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2017 Jun;56(6):649-660. doi: 10.1007/s40262-016-0473-5.
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, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
January 9, 2014
First Submitted That Met QC Criteria
January 9, 2014
First Posted (Estimate)
January 10, 2014
Study Record Updates
Last Update Posted (Estimate)
January 18, 2017
Last Update Submitted That Met QC Criteria
January 16, 2017
Last Verified
January 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
- NN1218-3887
- 2011-001580-41 (EudraCT Number)
- U1111-1120-3772 (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.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on Faster-acting insulin aspart
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 1Germany
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1United States, Germany
-
Novo Nordisk A/SCompleted
-
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
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1United States, Russian Federation, United Kingdom, Canada, France, Netherlands, Belgium, Germany, Slovenia
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Japan
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Germany
-
Novo Nordisk A/SCompleted
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Austria
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1Austria