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Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT01294436

Last Updated: 2013-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

728 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-09-30

Brief Summary

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This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.

Detailed Description

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Conditions

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Type2 Diabetes High Blood Sugar

Keywords

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Phase3 Clinical trial Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open label treatment

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Oral Dose 5 or 10 mg

Interventions

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Dapagliflozin

Oral Dose 5 or 10 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)
* diagnosed with type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started

Exclusion Criteria

* Type 1 diabetes mellitus,
* FPG \>240 mg/dL before treatment started
* Subjects who have history of unstable or rapidly progressing renal disease
* Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
* Significant cardiovascular 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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Dr Jisin Yang, MD

Role: STUDY_DIRECTOR

AstraZeneca KK

Locations

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Research Site

Nagoya, Aichi-ken, Japan

Site Status

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Owariasahi, Aichi-ken, Japan

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Toyohashi, Aichi-ken, Japan

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Hirosaki, Aomori, Japan

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Niihama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Itoshima, Fukuoka, Japan

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Yukuhashi, Fukuoka, Japan

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Annaka, Gunma, Japan

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Ōta, Gunma, Japan

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Aki-gun, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Sanuki, Kagawa-ken, Japan

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Takamatsu, Kagawa-ken, Japan

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Kamakura, Kanagawa, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Zushi, Kanagawa, Japan

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Kochi, Kochi, Japan

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Sendai, Miyagi, Japan

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Matsumoto, Nagano, Japan

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Osaka, Osaka, Japan

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Suita, Osaka, Japan

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Ōtsu, Shiga, Japan

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Atami, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Komatsushimachō, Tokushima, Japan

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Chiyoda City, Tokyo, Japan

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Chūō, Tokyo, Japan

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Mitaka, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Shibuya City, Tokyo, Japan

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Shinjuku, Tokyo, Japan

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Taitō City, Tokyo, Japan

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Takaoka, Toyama, Japan

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Toyama, Toyama, Japan

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Ube, Yamaguchi, Japan

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Countries

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Japan

Other Identifiers

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D1692C00012

Identifier Type: -

Identifier Source: org_study_id