Back to resultsA Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
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 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index below or equal to 35.0 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
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
NN5401 - low dose
NN5401 - medium dose
NN5401 - high dose
biphasic insulin aspart 30 - low dose
biphasic insulin aspart 30 - medium dose
biphasic insulin aspart 30 - high dose
Arm Description
Outcomes
Primary Outcome Measures
Area under the glucose infusion rate curve (only for IDegAsp)
Secondary Outcome Measures
Area under the insulin aspart concentration-time curve
Area under the insulin aspart concentration-time curve (only for BIAsp 30)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01134224
Brief Title
A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes
Official Title
A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
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
NN5401 - low dose
Arm Type
Experimental
Arm Title
NN5401 - medium dose
Arm Type
Experimental
Arm Title
NN5401 - high dose
Arm Type
Experimental
Arm Title
biphasic insulin aspart 30 - low dose
Arm Type
Active Comparator
Arm Title
biphasic insulin aspart 30 - medium dose
Arm Type
Active Comparator
Arm Title
biphasic insulin aspart 30 - high dose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
0.4 U/kg body weight injected subcutaneously (under the skin) once
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
0.6 U/kg body weight injected subcutaneously (under the skin) once
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
0.8 U/kg body weight injected subcutaneously (under the skin) once
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
0.4 U/kg body weight injected subcutaneously (under the skin) once
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
0.6 U/kg body weight injected subcutaneously (under the skin) once
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
0.8 U/kg body weight injected subcutaneously (under the skin) once
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve (only for IDegAsp)
Time Frame
From 0 to 24 hours after single-dose
Secondary Outcome Measure Information:
Title
Area under the insulin aspart concentration-time curve
Time Frame
From 0 to 12 hours after single-dose administration
Title
Area under the insulin aspart concentration-time curve (only for BIAsp 30)
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
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index below or equal to 35.0 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
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
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:
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes
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