Status:
COMPLETED
A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Collaborating Sponsors:
HNEC TEST
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6-65 years
Phase:
PHASE1
Brief Summary
This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diab...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index for children: 15.0-20.0 kg/m\^2 (both inclusive), for adolescents: 18.0-28.0 kg/m\^2 (both inclusive) and for adults maximum 30.0 kg/m\^2
Exclusion
- Subject who has donated any blood or plasma in the past month, or more than 500 mL within 3 months prior to screening
- Not able or willing to refrain from smoking during the inpatient period
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01138488
Start Date
June 1 2010
End Date
November 1 2010
Last Update
February 10 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Hanover, Germany, 30173