A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: Faster-acting insulin aspart; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT02033239

U1111-1120-3772 (Other Identifier)

NN1218-3887

2011-001580-41 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.

Enrollment: 46 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.5-28.0 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 screening
• Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
• Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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46 participants in 2 patient groups

FIAsp

Experimental group

Description:

Each subject will be randomised to a treatment sequence consisting of 8 treatment periods

Treatment:

Drug: Faster-acting insulin aspart

NovoRapid®

Active Comparator group

Description:

Each subject will be randomised to a treatment sequence consisting of 8 treatment periods

Treatment:

Drug: insulin aspart