Double-blind Comparative Study of TAK-875

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01433393
First received: September 12, 2011
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: TAK-875
Drug: Placebo
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:
  • HbA1c [ Designated as safety issue: No ]

Enrollment: 192
Study Completion Date: September 2012
Primary Completion Date: September 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
Placebo Comparator: Placebo Drug: Placebo

  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: NCT01433393

Locations
Japan
Kisarazu-shi, Chiba, Japan
Matsuyama-shi, Ehime, Japan
Fukuoka-shi Nishi-ku, Fukuoka, Japan
Kasuga-shi, Fukuoka, Japan
Naka-shi, Ibaragi, Japan
Tsuchiura-shi, Ibaragi, Japan
Takamatsu-shi, Kagawa, Japan
Kyoto-shi Fushimi-ku, Kyoto, Japan
Nagasaki-shi, Nagasaki, Japan
Kashihara-shi, Nara, Japan
Kashiwara-shi, Osaka, Japan
Osaka-shi Tsurumi-ku, Osaka, Japan
Sakai-shi Nishi-ku, Osaka, Japan
Shimotsuke-shi, Tochigi, Japan
Chiyoda-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Ota-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Toshima-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01433393     History of Changes
Other Study ID Numbers: TAK-875/CCT-003, U1111-1124-1518, JapicCTI-111604
Study First Received: September 12, 2011
Last Updated: November 7, 2012
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 29, 2014