NCT01934712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

August 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2014

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

August 30, 2013

Last Update Submit

December 7, 2018

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area under the serum insulin aspart concentration-time curve

    From 0-1 hour

Secondary Outcomes (3)

  • Area under the serum insulin aspart concentration-time curve

    From 0-12 hours

  • Area under the glucose infusion rate (GIR) curve

    From 0-1 hour

  • Area under the glucose infusion rate (GIR) curve

    From 0-12 hours

Study Arms (2)

FIAsp

EXPERIMENTAL

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

Drug: Faster-acting insulin aspartDrug: insulin aspart

NovoRapid®

ACTIVE COMPARATOR

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

Drug: Faster-acting insulin aspartDrug: insulin aspart

Interventions

Faster-acting insulin aspartDRUG

Single dose injected subcutaneously (s.c, under the skin)

FIAspNovoRapid®
insulin aspartDRUG

Single dose injected subcutaneously (s.c, under the skin)

FIAspNovoRapid®

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Fukuoka, 812-0025, Japan

Location

Related Publications (2)

  • Shiramoto M, Nishida T, Hansen AK, Haahr H. Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart. J Diabetes Investig. 2018 Mar;9(2):303-310. doi: 10.1111/jdi.12697. Epub 2017 Jul 7.

    PMID: 28556616BACKGROUND

  • Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.

    PMID: 30402720RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 4, 2013

Study Start

August 30, 2013

Primary Completion

January 28, 2014

Study Completion

January 28, 2014

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

JP(1)