Open-label Study of TAK-875

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01433419
First received: September 12, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Adverse events [ Designated as safety issue: Yes ]

Enrollment: 333
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-875 25 mg Drug: TAK-875
Experimental: TAK-875 50 mg Drug: TAK-875

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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: NCT01433419

Locations
Japan
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
Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01433419     History of Changes
Other Study ID Numbers: TAK-875/OCT-003, U1111-1124-1619, JapicCTI-111605
Study First Received: September 12, 2011
Last Updated: March 21, 2013
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 July 22, 2014