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Long-term Study of TAK-875

This study is currently recruiting participants.
Verified January 2013 by Takeda Global Research & Development Center, Inc.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01433406
First received: September 12, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of long-term 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:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

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

Estimated Enrollment: 1130
Arms Assigned Interventions
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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433406

Contacts
Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com

  Show 72 Study Locations
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier: NCT01433406     History of Changes
Other Study ID Numbers: TAK-875/OCT-002, U1111-1124-1561, JapicCTI-111602
Study First Received: September 12, 2011
Last Updated: January 17, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda Global Research & Development Center, Inc.:
Drug Therapy

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

ClinicalTrials.gov processed this record on May 19, 2013