Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
NCT ID: NCT01464099
Last Updated: 2016-10-28
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
24 participants
INTERVENTIONAL
2008-06-30
2008-11-30
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
DOUBLE
Study Groups
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Insulin aspart 100U/mL
insulin aspart
An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
Insulin aspart 200U/mL
insulin aspart
An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
Interventions
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insulin aspart
An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
insulin aspart
An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
Eligibility Criteria
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Inclusion Criteria
* BMI (Body Mass Index) between 18.0-29.0 kg/m\^2
* Negative fasting C-peptide (below or equal to 0.6 ng/mL)
* HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
* Current treatment with insulin below or equal to 1.2 U/kg/day
* Subject should be in good health based on medical history, physical examination and routine laboratory data
Exclusion Criteria
* A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
* Clinically significant active disease of any kind
* Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
* Blood donation (more than 500 mL) within the previous 9 weeks
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
Chula Vista, California, United States
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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ANA-3501
Identifier Type: -
Identifier Source: org_study_id