A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01924637

2011-000941-19 (EudraCT Number)

NN1218-3889

U1111-1119-5708 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in subjects with type 1 diabetes.

Enrollment: 36 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period inpatient period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

36 participants in 2 patient groups

FIASP

Experimental group

Description:

Each treatment period consists of 1 dosing visit during which the subject will receive a single dose of either insulin aspart or FIAsp at a predefined fixed dose level (in random sequence) in connection to intake of a standardised meal.

Treatment:

Drug: Faster-acting insulin aspart

NovoRapid®

Active Comparator group

Description:

Each treatment period consists of 1 dosing visit during which the subject will receive a single dose of either insulin aspart or FIAsp at a predefined fixed dose level (in random sequence) in connection to intake of a standardised meal.

Treatment:

Drug: insulin aspart