Overview

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

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Biphasic Insulins
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Criteria
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