A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin degludec

Drug: insulin degludec/insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT01590836

2011-003797-90 (EudraCT Number)

NN5401-1979

U1111-1123-3837 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.

Enrollment

22 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive)
Glycosylated haemoglobin (HbA1c) maximum 9.5 %
Fasting C-peptide maximum 0.3 nmol/L

Exclusion criteria

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, use of nicotine gum or transdermal nicotine patches during the inpatient period
Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening