A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese 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

NCT01934712

JapicCTI-132253 (Registry Identifier)

NN1218-3918

U1111-1121-2896 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.

Enrollment: 50 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
• Body mass index (BMI) 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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50 participants in 2 patient groups

FIAsp

Experimental group

Description:

Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits

Treatment:

Drug: insulin aspart

Drug: Faster-acting insulin aspart

NovoRapid®

Active Comparator group

Description:

Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits

Treatment:

Drug: insulin aspart

Drug: Faster-acting insulin aspart