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NCT01934712

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

NCT ID: NCT01934712

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-30

Study Completion Date

2014-01-28

Brief Summary

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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

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FIAsp

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

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

NovoRapid®

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

Group Type ACTIVE_COMPARATOR

Faster-acting insulin aspart

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

Interventions

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Faster-acting insulin aspart

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

Intervention Type DRUG

insulin aspart

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Fukuoka, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND

PMID: 28556616 (View on PubMed)

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.

Reference Type RESULT

PMID: 30402720 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN1218-3918

Identifier Type: -

Identifier Source: org_study_id

U1111-1121-2896

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-132253

Identifier Type: REGISTRY

Identifier Source: secondary_id