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Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients

NCT ID: NCT01055652

Last Updated: 2011-10-17

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessment of AUC and Cmax of dapagliflozin

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

10mg, oral, once daily

Interventions

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Dapagliflozin

10mg, oral, once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Already on voglibose treatment with a steady dosage for at least 8 weeks
* Provision of informed consent prior to any study specific procedures
* Diagnosed with type 2 diabetes

Exclusion Criteria

* Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
* The investigator(s)judged that the Subject should not participate in the study according to screening test or medical history.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nobuyuki Shiga

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Moriya, , Japan

Site Status

Research Site

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D1692C00002

Identifier Type: -

Identifier Source: org_study_id