Long-term Study of TAK-875

January 24, 2014 updated by: Takeda
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with TAK-875 in diabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1222

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan
    • Chiba
      • Chiba-shi, Chiba, Japan
      • Funabashi-shi, Chiba, Japan
      • Katori-shi, Chiba, Japan
      • Kisarazu-shi, Chiba, Japan
      • Matsudo-shi, Chiba, Japan
    • Ehime
      • Matsuyama-shi, Ehime, Japan
      • Nihama-shi, Ehime, Japan
      • Saijo-shi, Ehime, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Kitakyushu-shi, Fukuoka, Japan
      • Onga-gun, Fukuoka, Japan
    • Gunma
      • Annaka-shi, Gunma, Japan
      • Takasaki-shi, Gunma, Japan
    • Hiroshima
      • Aki-gun, Hiroshima, Japan
      • Hiroshima-shi, Hiroshima, Japan
    • Hokkaido
      • Chitose-shi, Hokkaido, Japan
      • Sapporo-shi, Hokkaido, Japan
    • Hyougo
      • Amagasaki-shi, Hyougo, Japan
      • Nishinomiya-shi, Hyougo, Japan
    • Ibaragi
      • Mito-shi, Ibaragi, Japan
      • Naka-shi, Ibaragi, Japan
      • Tsuchiura-shi, Ibaragi, Japan
      • Ushiku-shi, Ibaragi, Japan
    • Kagawa
      • Sakade-shi, Kagawa, Japan
    • Kagoshima
      • Izumi-shi, Kagoshima, Japan
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan
      • Yamato-shi, Kanagawa, Japan
    • Kochi
      • Kochi-shi, Kochi, Japan
      • Suzaki-shi, Kochi, Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
      • Minamata-shi, Kumamoto, Japan
    • Kyoto
      • Uji-shi, Kyoto, Japan
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan
    • Nagano
      • Matsumoto-shi, Nagano, Japan
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan
      • Omura-shi, Nagasaki, Japan
    • Oita
      • Oita-shi, Oita, Japan
    • Okayama
      • Okayama-shi, Okayama, Japan
    • Osaka
      • 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
      • Saga-shi, Saga, Japan
    • Saitama
      • Fujimi-shi, Saitama, Japan
      • Saitama-shi, Saitama, Japan
      • Sayama-shi, Saitama, Japan
      • Tokorozawa-shi, Saitama, Japan
    • Shizuoka
      • Fujinomiya-shi, Shizuoka, Japan
      • Shizuoka-shi, Shizuoka, Japan
    • Siga
      • Otsu-shi, Siga, Japan
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan
      • Shimotsuke-shi, Tochigi, Japan
    • Tokushima
      • Komatsu-shi, Tokushima, Japan
    • Tokyo
      • 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
    • Yamaguchi
      • Sanyoonoda-shi, Yamaguchi, Japan
      • Shimonoseki-shi, Yamaguchi, Japan
      • Ube-shi, Yamaguchi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From Baseline to Week 53
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 12, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TAK-875/OCT-002
  • U1111-1124-1561 (Registry Identifier: WHO)
  • JapicCTI-111602 (Registry Identifier: JapicCTI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on TAK-875

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe