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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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