Back to resultsA Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
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:
- 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
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 randomised to a treatment sequence consisting of 8 treatment periods
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
Outcomes
Primary Outcome Measures
Area under the glucose infusion rate curve
Secondary Outcome Measures
Area under the serum insulin aspart concentration-time curve
Maximum glucose infusion rate
Maximum observed serum insulin aspart concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02033239
Brief Title
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
Official Title
A Trial Investigating the Pharmacodynamic Response of FIAsp in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 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 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.
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
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FIAsp
Arm Type
Experimental
Arm Description
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
Arm Title
NovoRapid®
Arm Type
Active Comparator
Arm Description
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
Intervention Type
Drug
Intervention Name(s)
Faster-acting insulin aspart
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
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).
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
From 0 to 12 hours
Secondary Outcome Measure Information:
Title
Area under the serum insulin aspart concentration-time curve
Time Frame
From 0 to 12 hours
Title
Maximum glucose infusion rate
Time Frame
Within 0 to 12 hours after dosing
Title
Maximum observed serum insulin aspart concentration
Time Frame
Within 0 to 12 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27878566
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
28205039
Citation
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.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
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