Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes

Completed · Phase 1

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

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 diabetes.

Key facts

Study ID

NCT01464099

Run by

Novo Nordisk A/S

People needed

24

Starts

2008-06-01

Expected to finish

2008-11-01

Last updated by the study team

2016-10-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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