A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
NCT ID: NCT01030926
Last Updated: 2017-01-20
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
39 participants
INTERVENTIONAL
2009-12-31
2010-05-31
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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A1, first period
insulin degludec
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
A2, second period
insulin glargine
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
B1, first period
insulin glargine
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
B2, second period
insulin degludec
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
Interventions
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insulin degludec
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
insulin glargine
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
6 Years
65 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
Hanover, , Germany
Countries
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References
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Biester T, Blaesig S, Remus K, Aschemeier B, Kordonouri O, Granhall C, Sondergaard F, Kristensen NR, Haahr H, Danne T. Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Feb;15(1):27-33. doi: 10.1111/pedi.12116.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-008306-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1112-4715
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-1995
Identifier Type: -
Identifier Source: org_study_id
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