A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes
NCT ID: NCT01174303
Last Updated: 2017-02-10
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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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2010-08-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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IDegAsp - BIAsp
insulin degludec/insulin aspart
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
biphasic insulin aspart 30
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
BIAsp - IDegAsp
insulin degludec/insulin aspart
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
biphasic insulin aspart 30
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
Interventions
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insulin degludec/insulin aspart
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
biphasic insulin aspart 30
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 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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Novo Nordisk Investigational Site
Graz, , Austria
Countries
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References
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Brunner M, Pieber T, Korsatko S, Kojzar H, Svendsen AL, Haahr H. The Distinct Prandial and Basal Pharmacodynamics of IDegAsp Observed in Younger Adults Are Preserved in Elderly Subjects with Type 1 Diabetes. Drugs Aging. 2015 Jul;32(7):583-90. doi: 10.1007/s40266-015-0272-y.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1114-9373
Identifier Type: OTHER
Identifier Source: secondary_id
2009-017280-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN5401-1981
Identifier Type: -
Identifier Source: org_study_id
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