Back to resultsA Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec/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 at least 12 months
- Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 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
- Not able or willing to refrain from smoking during the inpatient period
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NN5401
Arm Description
Outcomes
Primary Outcome Measures
Area under the serum insulin degludec concentration-time curve
Area under the serum insulin aspart concentration-time curve
Secondary Outcome Measures
Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed
Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed
Full Information
NCT ID
NCT01138488
First Posted
June 4, 2010
Last Updated
February 9, 2017
Sponsor
Novo Nordisk A/S
Collaborators
HNEC TEST
1. Study Identification
Unique Protocol Identification Number
NCT01138488
Brief Title
A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes
Official Title
A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
Collaborators
HNEC TEST
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NN5401
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).
Primary Outcome Measure Information:
Title
Area under the serum insulin degludec concentration-time curve
Time Frame
from 0 to infinity after single-dose
Title
Area under the serum insulin aspart concentration-time curve
Time Frame
from 0 to 12 hours after single-dose
Secondary Outcome Measure Information:
Title
Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed
Time Frame
from 0 to 57 hours after single-dose
Title
Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed
Time Frame
from 0 to 12 hours after single-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 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
Not able or willing to refrain from smoking during the inpatient period
Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
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
Hannover
ZIP/Postal Code
30173
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26782928
Citation
Biester T, Danne T, Blasig S, Remus K, Aschemeier B, Kordonouri O, Bardtrum L, Haahr H. Pharmacokinetic and prandial pharmacodynamic properties of insulin degludec/insulin aspart in children, adolescents, and adults with type 1 diabetes. Pediatr Diabetes. 2016 Dec;17(8):642-649. doi: 10.1111/pedi.12358. Epub 2016 Jan 18.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes
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