A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin degludec/insulin aspart

Drug: biphasic insulin aspart 30

Study type

Interventional

Funder types

Industry

Identifiers

NCT01174303

2009-017280-42 (EudraCT Number)

U1111-1114-9373 (Other Identifier)

NN5401-1981

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index 18.0-28.0 kg/m^2 (both inclusive)
HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis

Exclusion criteria

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
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