Open-label Study of TAK-875

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433419
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : March 22, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: TAK-875 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Intervention Model: Parallel Assignment
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: TAK-875 25 mg Drug: TAK-875
Experimental: TAK-875 50 mg Drug: TAK-875

Primary Outcome Measures :
  1. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433419

Katori-shi, Chiba, Japan
Niihama-shi, Ehime, Japan
Chikushino-shi, Fukuoka, Japan
Fukuoka-shi, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Yukuhashi-shi, Fukuoka, Japan
Hiroshima-shi, Hiroshima, Japan
Chitose-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Koga-shi, Ibaragi, Japan
Ushiku-shi, Ibaragi, Japan
Chigasaki-shi, Kanagawa, Japan
Kamakura-shi, Kanagawa, Japan
Minamata-shi, Kumamoto, Japan
Yatsushiro-shi, Kumamoto, Japan
Sasebo-shi, Nagasaki, Japan
Kashihara-shi, Nara, Japan
Okinawa-shi, Okinawa, Japan
Izumi-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Fujimi-shi, Saitama, Japan
Shimotsuga-gun, Tochigi, Japan
Komatsushima-shi, Tokushima, Japan
Bunkyo-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Toshima-ku, Tokyo, Japan
Shunan-shi, Yamaguchi, Japan
Ube-shi, Yamaguchi, Japan
Sponsors and Collaborators

Responsible Party: Takeda Identifier: NCT01433419     History of Changes
Other Study ID Numbers: TAK-875/OCT-003
U1111-1124-1619 ( Registry Identifier: WHO )
JapicCTI-111605 ( Registry Identifier: JapicCTI )
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013

Keywords provided by Takeda:
Drug Therapy

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