Status:
COMPLETED
A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.
Eligibility Criteria
Inclusion
- Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m\^2 (both inclusive)
- HbA1c (glycosylated haemoglobin A1c) maximum 10.0% 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 :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01174303
Start Date
August 1 2010
End Date
November 1 2010
Last Update
February 10 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Graz, Austria, 8036