Long-term Study of TAK-875

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01433406
First received: September 12, 2011
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: TAK-875
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Adverse events [ Time Frame: From Baseline to Week 53 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1222
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-875 25 mg
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
Drug: TAK-875
Experimental: TAK-875 50 mg
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
Drug: TAK-875

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433406

  Hide Study Locations
Locations
Japan
Nagoya-shi, Aichi, Japan
Chiba-shi, Chiba, Japan
Funabashi-shi, Chiba, Japan
Katori-shi, Chiba, Japan
Kisarazu-shi, Chiba, Japan
Matsudo-shi, Chiba, Japan
Matsuyama-shi, Ehime, Japan
Nihama-shi, Ehime, Japan
Saijo-shi, Ehime, Japan
Fukuoka-shi, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Annaka-shi, Gunma, Japan
Takasaki-shi, Gunma, Japan
Aki-gun, Hiroshima, Japan
Hiroshima-shi, Hiroshima, Japan
Chitose-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Amagasaki-shi, Hyougo, Japan
Nishinomiya-shi, Hyougo, Japan
Mito-shi, Ibaragi, Japan
Naka-shi, Ibaragi, Japan
Tsuchiura-shi, Ibaragi, Japan
Ushiku-shi, Ibaragi, Japan
Sakade-shi, Kagawa, Japan
Izumi-shi, Kagoshima, Japan
Kamakura-shi, Kanagawa, Japan
Yamato-shi, Kanagawa, Japan
Kochi-shi, Kochi, Japan
Suzaki-shi, Kochi, Japan
Kumamoto-shi, Kumamoto, Japan
Minamata-shi, Kumamoto, Japan
Uji-shi, Kyoto, Japan
Miyazaki-shi, Miyazaki, Japan
Matsumoto-shi, Nagano, Japan
Nagasaki-shi, Nagasaki, Japan
Omura-shi, Nagasaki, Japan
Oita-shi, Oita, Japan
Okayama-shi, Okayama, Japan
Izumisano-shi, Osaka, Japan
Kashiwara-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Sakai-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Toyonaka-shi, Osaka, Japan
Saga-shi, Saga, Japan
Fujimi-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Sayama-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Fujinomiya-shi, Shizuoka, Japan
Shizuoka-shi, Shizuoka, Japan
Otsu-shi, Siga, Japan
Shimotsuga-gun, Tochigi, Japan
Shimotsuke-shi, Tochigi, Japan
Komatsu-shi, Tokushima, Japan
Bunkyo-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Hino-shi, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Katsushika-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan
Nerima-ku, Tokyo, Japan
Ota-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Sibuya-ku, Tokyo, Japan
Toyoshima-ku, Tokyo, Japan
Sanyoonoda-shi, Yamaguchi, Japan
Shimonoseki-shi, Yamaguchi, Japan
Ube-shi, Yamaguchi, Japan
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01433406     History of Changes
Other Study ID Numbers: TAK-875/OCT-002, U1111-1124-1561, JapicCTI-111602
Study First Received: September 12, 2011
Last Updated: January 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014