Status:
COMPLETED
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01455142
Start Date
October 1 2011
End Date
January 1 2012
Last Update
February 23 2015
Active Locations (1)
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1
Graz, Austria, 8010