Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
NCT ID: NCT01868529
Last Updated: 2015-09-28
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
63 participants
INTERVENTIONAL
2008-01-31
2008-06-30
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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Low dose
insulin degludec
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
insulin glargine
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
Medium dose
insulin degludec
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
insulin glargine
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
High dose
insulin degludec
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
insulin glargine
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
Interventions
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insulin degludec
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
insulin glargine
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
Eligibility Criteria
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Inclusion Criteria
* Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Body Mass Index (BMI) between 18.0 and 28.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
* Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day
Exclusion Criteria
* Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
* Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
18 Years
69 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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2007-003534-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1250-1876
Identifier Type: -
Identifier Source: org_study_id
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