Clinical trial NCT01433406: Long-term Study of TAK-875
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 1222
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

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


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events
timeFrame: From Baseline to Week 53
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Chiba-shi
country: Japan
state: Chiba
city: Funabashi-shi
country: Japan
state: Chiba
city: Katori-shi
country: Japan
state: Chiba
city: Kisarazu-shi
country: Japan
state: Chiba
city: Matsudo-shi
country: Japan
state: Chiba
city: Matsuyama-shi
country: Japan
state: Ehime
city: Nihama-shi
country: Japan
state: Ehime
city: Saijo-shi
country: Japan
state: Ehime
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Annaka-shi
country: Japan
state: Gunma
city: Takasaki-shi
country: Japan
state: Gunma
city: Aki-gun
country: Japan
state: Hiroshima
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Chitose-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Amagasaki-shi
country: Japan
state: Hyougo
city: Nishinomiya-shi
country: Japan
state: Hyougo
city: Mito-shi
country: Japan
state: Ibaragi
city: Naka-shi
country: Japan
state: Ibaragi
city: Tsuchiura-shi
country: Japan
state: Ibaragi
city: Ushiku-shi
country: Japan
state: Ibaragi
city: Sakade-shi
country: Japan
state: Kagawa
city: Izumi-shi
country: Japan
state: Kagoshima
city: Kamakura-shi
country: Japan
state: Kanagawa
city: Yamato-shi
country: Japan
state: Kanagawa
city: Kochi-shi
country: Japan
state: Kochi
city: Suzaki-shi
country: Japan
state: Kochi
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Minamata-shi
country: Japan
state: Kumamoto
city: Uji-shi
country: Japan
state: Kyoto
city: Miyazaki-shi
country: Japan
state: Miyazaki
city: Matsumoto-shi
country: Japan
state: Nagano
city: Nagasaki-shi
country: Japan
state: Nagasaki
city: Omura-shi
country: Japan
state: Nagasaki
city: Oita-shi
country: Japan
state: Oita
city: Okayama-shi
country: Japan
state: Okayama
city: Izumisano-shi
country: Japan
state: Osaka
city: Kashiwara-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Toyonaka-shi
country: Japan
state: Osaka
city: Saga-shi
country: Japan
state: Saga
city: Fujimi-shi
country: Japan
state: Saitama
city: Saitama-shi
country: Japan
state: Saitama
city: Sayama-shi
country: Japan
state: Saitama
city: Tokorozawa-shi
country: Japan
state: Saitama
city: Fujinomiya-shi
country: Japan
state: Shizuoka
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Otsu-shi
country: Japan
state: Siga
city: Shimotsuga-gun
country: Japan
state: Tochigi
city: Shimotsuke-shi
country: Japan
state: Tochigi
city: Komatsu-shi
country: Japan
state: Tokushima
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Hino-shi
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Katsushika-ku
country: Japan
state: Tokyo
city: Mitaka-shi
country: Japan
state: Tokyo
city: Nerima-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Sibuya-ku
country: Japan
state: Tokyo
city: Toyoshima-ku
country: Japan
state: Tokyo
city: Sanyoonoda-shi
country: Japan
state: Yamaguchi
city: Shimonoseki-shi
country: Japan
state: Yamaguchi
city: Ube-shi
country: Japan
state: Yamaguchi
Study officials:
References: