A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics
NCT ID: NCT00964964
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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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2009-08-31
2009-09-30
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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SIBA 3W
insulin degludec
Insulin degludec injected s.c. (under the skin) three times weekly
placebo
Placebo injected s.c. (under the skin) four times weekly
SIBA OD
insulin degludec
Insulin degludec injected s.c. (under the skin) once daily for one week
Interventions
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insulin degludec
Insulin degludec injected s.c. (under the skin) three times weekly
insulin degludec
Insulin degludec injected s.c. (under the skin) once daily for one week
placebo
Placebo injected s.c. (under the skin) four times weekly
Eligibility Criteria
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Inclusion Criteria
* Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)
Exclusion Criteria
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods
* Prior or current treatment with metformin or thiazolidinediones
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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Neuss, , Germany
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2009-011959-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1250-3765
Identifier Type: -
Identifier Source: org_study_id