Long-term Study of TAK-875

NCT ID: NCT01433406

Last Updated: 2014-01-27

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

PHASE3

Total Enrollment

1222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of long-term treatment with TAK-875 in diabetic patients.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Intervention Model

PARALLEL

Study Groups

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TAK-875 25 mg

(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)

Group Type EXPERIMENTAL

TAK-875

Intervention Type DRUG

TAK-875 50 mg

(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)

Group Type EXPERIMENTAL

TAK-875

Intervention Type DRUG

Interventions

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TAK-875

Intervention Type DRUG

TAK-875

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. The participant is an outpatient.
2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria

1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nagoya, Aichi-ken, Japan

Site Status

Chiba, Chiba, Japan

Site Status

Funabashi-shi, Chiba, Japan

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Katori-shi, Chiba, Japan

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Kisarazu-shi, Chiba, Japan

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Matsudo-shi, Chiba, Japan

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Matsuyama, Ehime, Japan

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Nihama-shi, Ehime, Japan

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Saijo-shi, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu-shi, Fukuoka, Japan

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Onga-gun, Fukuoka, Japan

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Annaka-shi, Gunma, Japan

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Takasaki-shi, Gunma, Japan

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Aki-gun, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

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Chitose-shi, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki-shi, Hyōgo, Japan

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Nishinomiya-shi, Hyōgo, Japan

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Mito, Ibaragi, Japan

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Naka, Ibaragi, Japan

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Tsuchiura-shi, Ibaragi, Japan

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Ushiku-shi, Ibaragi, Japan

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Sakade-shi, Kagawa-ken, Japan

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Izumi-shi, Kagoshima-ken, Japan

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Kamakura-shi, Kanagawa, Japan

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Yamato-shi, Kanagawa, Japan

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Kochi, Kochi, Japan

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Suzaki-shi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Minamata-shi, Kumamoto, Japan

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Uji-shi, Kyoto, Japan

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Miyazaki, Miyazaki, Japan

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Matsumoto-shi, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Omura-shi, Nagasaki, Japan

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Ōita, Oita Prefecture, Japan

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Okayama, Okayama-ken, Japan

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Izumisano, Osaka, Japan

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Kashiwara-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai-shi, Osaka, Japan

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Suita-shi, Osaka, Japan

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Toyonaka-shi, Osaka, Japan

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Saga, Saga-ken, Japan

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Fujimi-shi, Saitama, Japan

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Saitama-shi, Saitama, Japan

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Sayama-shi, Saitama, Japan

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Tokorozawa-shi, Saitama, Japan

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Ōtsu, Shiga, Japan

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Fujinomiya-shi, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Shimotsuga-gun, Tochigi, Japan

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Shimotsuke-shi, Tochigi, Japan

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Komatsu-shi, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Chuo-ku, Tokyo, Japan

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Hino-shi, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Katsushika-ku, Tokyo, Japan

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Mitaka-shi, Tokyo, Japan

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Nerima-ku, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Sibuya-ku, Tokyo, Japan

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Toyoshima-ku, Tokyo, Japan

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Sanyoonoda-shi, Yamaguchi, Japan

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Shimonoseki-shi, Yamaguchi, Japan

Site Status

Ube-shi, Yamaguchi, Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1124-1561

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-111602

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-875/OCT-002

Identifier Type: -

Identifier Source: org_study_id

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