A Comparison Between Two Formulations of NN5401 in Healthy Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin degludec/insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125553

NN5401-1980

U1111-1113-7011 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

26 participants in 2 patient groups

IDegAsp B

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

IDegAsp F

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart