Status:
TERMINATED
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Jap...
Eligibility Criteria
Inclusion
- Male or female Japanese subject aged 20-70 years (both inclusive)
- Japanese passport holder
- Japanese-born parents
- Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Treated with insulin for at least 3 months
- Body Mass Index (BMI) maximum 33.0 kg/m\^2
- Glycosylated haemoglobin A1c (HbA1c) maximum 10.0%
- Fasting C-peptide below 1.0 nmol/L
Exclusion
- Use of oral antidiabetic drugs (OADs) and/or glucagon like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
- 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 and use of nicotine gum or transdermal nicotine patches during the inpatient period
- Supine blood pressure at screening (after resting for 5 min) minimum 180 mmHg for systolic and/or minimum 100 mmHg for diastolic
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01467414
Start Date
October 1 2011
End Date
December 1 2011
Last Update
November 27 2013
Active Locations (1)
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1
Neuss, Germany, 41460