Status:
COMPLETED
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically r...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m\^2 (both inclusive)
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)
- Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
- 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 :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00993096
Start Date
September 1 2009
End Date
December 1 2009
Last Update
February 10 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460