Back to resultsA Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults 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 glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 6-65 years (both inclusive)
- 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 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Experimental
Arm Label
A1, first period
A2, second period
B1, first period
B2, second period
Arm Description
Outcomes
Primary Outcome Measures
Area under the NN1250 concentration-time curve after single dose
Secondary Outcome Measures
Maximum observed NN1250 concentration after single dose
Time to maximum observed NN1250 concentration after single dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01030926
Brief Title
A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
Official Title
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (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 was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults 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
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1, first period
Arm Type
Experimental
Arm Title
A2, second period
Arm Type
Active Comparator
Arm Title
B1, first period
Arm Type
Active Comparator
Arm Title
B2, second period
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
Primary Outcome Measure Information:
Title
Area under the NN1250 concentration-time curve after single dose
Time Frame
0-72 hours after dosing
Secondary Outcome Measure Information:
Title
Maximum observed NN1250 concentration after single dose
Time Frame
0-72 hours after dosing
Title
Time to maximum observed NN1250 concentration after single dose
Time Frame
0-72 hours after dosing
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:
Male or female aged 6-65 years (both inclusive)
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
24467565
Citation
Biester T, Blaesig S, Remus K, Aschemeier B, Kordonouri O, Granhall C, Sondergaard F, Kristensen NR, Haahr H, Danne T. Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Feb;15(1):27-33. doi: 10.1111/pedi.12116.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
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