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

September 12, 2011
September 14, 2011
November 9, 2012
Not Provided
September 2012   (Final data collection date for primary outcome measure)
HbA1c
Same as current
Complete list of historical versions of study NCT01433393 on ClinicalTrials.gov Archive Site
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Double-blind Comparative Study of TAK-875
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The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.
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Interventional
Phase 3
Intervention Model: Parallel Assignment
Diabetes Mellitus
  • Drug: TAK-875
  • Drug: Placebo
  • Experimental: TAK-875 25 mg
    Intervention: Drug: TAK-875
  • Experimental: TAK-875 50 mg
    Intervention: Drug: TAK-875
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
September 2012
September 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01433393
TAK-875/CCT-003
U1111-1124-1518 ( Registry Identifier: WHO )
JapicCTI-111604 ( Registry Identifier: JapicCTI )
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Takeda
Takeda
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Not Provided
Takeda
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP