Back to resultsA Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Faster-acting insulin aspart
insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FIAsp
NovoRapid®
Arm Description
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
Outcomes
Primary Outcome Measures
Area under the serum insulin aspart concentration-time curve
Secondary Outcome Measures
Area under the serum insulin aspart concentration-time curve
Area under the glucose infusion rate (GIR) curve
Area under the glucose infusion rate (GIR) curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01934712
Brief Title
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
Official Title
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 30, 2013 (Actual)
Primary Completion Date
January 28, 2014 (Actual)
Study Completion Date
January 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FIAsp
Arm Type
Experimental
Arm Description
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
Arm Title
NovoRapid®
Arm Type
Active Comparator
Arm Description
Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
Intervention Type
Drug
Intervention Name(s)
Faster-acting insulin aspart
Intervention Description
Single dose injected subcutaneously (s.c, under the skin)
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Single dose injected subcutaneously (s.c, under the skin)
Primary Outcome Measure Information:
Title
Area under the serum insulin aspart concentration-time curve
Time Frame
From 0-1 hour
Secondary Outcome Measure Information:
Title
Area under the serum insulin aspart concentration-time curve
Time Frame
From 0-12 hours
Title
Area under the glucose infusion rate (GIR) curve
Time Frame
From 0-1 hour
Title
Area under the glucose infusion rate (GIR) curve
Time Frame
From 0-12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28556616
Citation
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.
Results Reference
background
PubMed Identifier
30402720
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes
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