Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
NCT ID: NCT01002768
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
28 participants
INTERVENTIONAL
2009-10-31
2010-03-31
Brief Summary
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The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.
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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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IDeg
insulin degludec
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
IGlar
insulin glargine
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
Interventions
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insulin degludec
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
insulin glargine
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
Eligibility Criteria
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Inclusion Criteria
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)
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
* Smoker
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
18 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
Graz, , Austria
Countries
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References
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Koehler G, Heller S, Korsatko S, Roepstorff C, Rasmussen S, Haahr H, Pieber TR. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study. Diabetologia. 2014 Jan;57(1):40-9. doi: 10.1007/s00125-013-3056-0. Epub 2013 Sep 22.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1111-8843
Identifier Type: OTHER
Identifier Source: secondary_id
2008-008356-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1250-3538
Identifier Type: -
Identifier Source: org_study_id
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