Status:
COMPLETED
Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 di...
Eligibility Criteria
Inclusion
- Subjects with type 1 diabetes treated with insulin for at least 12 months
- 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
- Any known/suspected allergies to trial medication or similar products/devices
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01464099
Start Date
June 1 2008
End Date
November 1 2008
Last Update
October 28 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Chula Vista, California, United States, 91911