- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455142
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
February 19, 2015 updated by: Novo Nordisk A/S
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8010
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Formulation 1
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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).
Other Names:
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Experimental: Formulation 2
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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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the serum insulin degludec concentration-time curve
Time Frame: From 0 to 120 hours after single-dose (SD)
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From 0 to 120 hours after single-dose (SD)
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Maximum observed serum insulin degludec concentration
Time Frame: After single-dose (within 0 to 120 hours after dosing)
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After single-dose (within 0 to 120 hours after dosing)
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Area under the serum insulin aspart concentration-time curve
Time Frame: From 0 to 12 hours after single-dose
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From 0 to 12 hours after single-dose
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Maximum observed serum insulin aspart concentration
Time Frame: After single-dose (within 0 to 12 hours after dosing)
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After single-dose (within 0 to 12 hours after dosing)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the glucose infusion rate curve
Time Frame: From 0 to 26 hours after single-dose
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From 0 to 26 hours after single-dose
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Maximum glucose infusion rate
Time Frame: After single-dose (within 0 to 120 hours after dosing)
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After single-dose (within 0 to 120 hours after dosing)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
October 17, 2011
First Submitted That Met QC Criteria
October 18, 2011
First Posted (Estimate)
October 19, 2011
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 19, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1045-3834
- 2011-001569-42 (EudraCT Number)
- U1111-1120-3922 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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