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Double-blind Comparative Study of TAK-875

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ClinicalTrials.gov Identifier: NCT01433393
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : November 9, 2012
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Intervention Model: Parallel Assignment
Primary Completion Date : September 2012
Study Completion Date : September 2012
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. HbA1c

Eligibility Criteria

Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01433393     History of Changes
Other Study ID Numbers: TAK-875/CCT-003
U1111-1124-1518 ( Registry Identifier: WHO )
JapicCTI-111604 ( Registry Identifier: JapicCTI )
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Takeda:
Drug Therapy

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