A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
NCT ID: NCT01569841
Last Updated: 2016-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2012-04-30
2012-11-30
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
NONE
Study Groups
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IDeg
insulin degludec
Administered subcutaneously (s.c., under the skin) once daily.
IGlar
insulin glargine
Administered subcutaneously (s.c., under the skin) once daily.
Interventions
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insulin degludec
Administered subcutaneously (s.c., under the skin) once daily.
insulin glargine
Administered subcutaneously (s.c., under the skin) once daily.
Eligibility Criteria
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Inclusion Criteria
* HbA1c (glycosylated haemoglobin) below or equal to 8.5%
* Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
* BMI (body mass index) below 35 kg/m\^2
Exclusion Criteria
* Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
* Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
* Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months
18 Years
75 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 Clinical Trial Call Center
Minneapolis, Minnesota, United States
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1125-7495
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-3874
Identifier Type: -
Identifier Source: org_study_id
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