A Comparison Between Two Formulations of NN5401 in Healthy Subjects

Completed · Phase 1

Conditions studied: Diabetes, Healthy

In brief

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.

Key facts

Study ID

NCT01125553

Run by

Novo Nordisk A/S

People needed

26

Starts

2010-05-01

Expected to finish

2010-08-01

Last updated by the study team

2015-09-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the physician
• Body mass index between 18.0 and 27.0 kg/m\^2 (both inclusive)

You may not qualify if…

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Where it is running

• Novo Nordisk Clinical Trial Call Center — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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