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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: Faster-acting insulin aspart; Drug: insulin aspart

• Registration Number: NCT01934712
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-30
• Study First Submitted: 2013-08-30
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-04
• Primary Completion: 2014-01-28
• Study Completion: 2014-01-28
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FIAsp	Faster-acting insulin aspart	Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
NovoRapid®	Faster-acting insulin aspart	Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
FIAsp	insulin aspart	Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits
NovoRapid®	insulin aspart	Each subject will be randomly allocated to one of the two treatment sequences consisting of 2 dosing visits

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve	From 0-1 hour

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve	From 0-12 hours
Area under the glucose infusion rate (GIR) curve	From 0-12 hours

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Fukuoka, Japan