Long-term Study of TAK-875

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01433406
First received: September 12, 2011
Last updated: January 24, 2014
Last verified: January 2014
  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

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Adverse events [ Time Frame: From Baseline to Week 53 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1222
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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
Accepts Healthy Volunteers:   No
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: NCT01433406

  Show 71 Study Locations
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
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 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

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

ClinicalTrials.gov processed this record on October 23, 2014