A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes
NCT ID: NCT01467414
Last Updated: 2013-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
1 participants
INTERVENTIONAL
2011-10-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NN1250
insulin degludec
Injected s.c. (under the skin) once daily for 6 days
Interventions
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insulin degludec
Injected s.c. (under the skin) once daily for 6 days
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
20 Years
70 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Neuss, , Germany
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2011-001850-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1120-7444
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-3763
Identifier Type: -
Identifier Source: org_study_id