Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec/insulin aspart
insulin degludec/insulin aspart
insulin degludec/insulin aspart
biphasic insulin aspart 30
biphasic insulin aspart 30
biphasic insulin aspart 30
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 18.0-28.0 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 more than 5 cigarettes or the equivalent per day)
- Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
IDegAsp low
IDegAsp middle
IDegAsp high
BIAsp 30 low
BIAsp 30 middle
BIAsp 30 high
Arm Description
Outcomes
Primary Outcome Measures
Area (AUC) under the glucose infusion rate curve
Secondary Outcome Measures
Area (AUC) under the insulin aspart concentration time curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00993096
Brief Title
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
Official Title
A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (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 evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.
The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.
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
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDegAsp low
Arm Type
Experimental
Arm Title
IDegAsp middle
Arm Type
Experimental
Arm Title
IDegAsp high
Arm Type
Experimental
Arm Title
BIAsp 30 low
Arm Type
Experimental
Arm Title
BIAsp 30 middle
Arm Type
Experimental
Arm Title
BIAsp 30 high
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Primary Outcome Measure Information:
Title
Area (AUC) under the glucose infusion rate curve
Time Frame
From 0 to 24 hours after single-dose administration
Secondary Outcome Measure Information:
Title
Area (AUC) under the insulin aspart concentration time curve
Time Frame
From 0 to 24 hours after single-dose administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 18.0-28.0 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 more than 5 cigarettes or the equivalent per day)
Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches 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
25772444
Citation
Heise T, Nosek L, Klein O, Coester H, Svendsen AL, Haahr H. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):659-64. doi: 10.1111/dom.12463. Epub 2015 May 1.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
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