Long-term Study of TAK-875
3 other identifiers
interventional
1,222
1 country
71
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with TAK-875 in diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus
Started Oct 2011
71 active sites
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
September 12, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 27, 2014
January 1, 2014
2.2 years
September 12, 2011
January 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
From Baseline to Week 53
Study Arms (2)
TAK-875 25 mg
EXPERIMENTAL(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
TAK-875 50 mg
EXPERIMENTAL(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
Interventions
Eligibility Criteria
You may qualify if:
- The participant is an outpatient.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
You may not qualify if:
- The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (71)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Chiba, Chiba, Japan
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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
Unknown Facility
Itabashi-ku, Tokyo, Japan
Unknown Facility
Katsushika-ku, Tokyo, Japan
Unknown Facility
Mitaka-shi, Tokyo, Japan
Unknown Facility
Nerima-ku, Tokyo, Japan
Unknown Facility
Ōta-ku, Tokyo, Japan
Unknown Facility
Shinjuku-ku, Tokyo, Japan
Unknown Facility
Sibuya-ku, Tokyo, Japan
Unknown Facility
Toyoshima-ku, Tokyo, Japan
Unknown Facility
Sanyoonoda-shi, Yamaguchi, Japan
Unknown Facility
Shimonoseki-shi, Yamaguchi, Japan
Unknown Facility
Ube-shi, Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2011
First Posted
September 14, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 27, 2014
Record last verified: 2014-01