Back to resultsA Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Austria
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 12 months or longer
- Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
- HbA1c below or equal to 9.5% by central laboratory analysis
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 Type
Experimental
Experimental
Arm Label
Formulation 1
Formulation 2
Arm Description
Outcomes
Primary Outcome Measures
Area under the serum insulin degludec concentration-time curve
Maximum observed serum insulin degludec concentration
Area under the serum insulin aspart concentration-time curve
Maximum observed serum insulin aspart concentration
Secondary Outcome Measures
Area under the glucose infusion rate curve
Maximum glucose infusion rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01455142
Brief Title
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
Official Title
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (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 the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.
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
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Formulation 1
Arm Type
Experimental
Arm Title
Formulation 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Other Intervention Name(s)
IDegAsp
Intervention Description
Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Primary Outcome Measure Information:
Title
Area under the serum insulin degludec concentration-time curve
Time Frame
From 0 to 120 hours after single-dose (SD)
Title
Maximum observed serum insulin degludec concentration
Time Frame
After single-dose (within 0 to 120 hours after dosing)
Title
Area under the serum insulin aspart concentration-time curve
Time Frame
From 0 to 12 hours after single-dose
Title
Maximum observed serum insulin aspart concentration
Time Frame
After single-dose (within 0 to 12 hours after dosing)
Secondary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
From 0 to 26 hours after single-dose
Title
Maximum glucose infusion rate
Time Frame
After single-dose (within 0 to 120 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:
Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
HbA1c below or equal to 9.5% by central laboratory analysis
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
Graz
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
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