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

September 12, 2011
January 24, 2014
October 2011
December 2013   (final data collection date for primary outcome measure)
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.
Adverse events [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01433406 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-term Study of TAK-875
Not Provided

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

Not Provided
Interventional
Phase 3
Intervention Model: Parallel Assignment
Diabetes Mellitus
Drug: TAK-875
  • Experimental: TAK-875 25 mg
    (long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
    Intervention: Drug: TAK-875
  • Experimental: TAK-875 50 mg
    (long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
    Intervention: Drug: TAK-875
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1222
December 2013
December 2013   (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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01433406
TAK-875/OCT-002, U1111-1124-1561, JapicCTI-111602
No
Takeda
Takeda
Not Provided
Not Provided
Takeda
January 2014

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