Long-term Study of TAK-875

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433406
• Other study ID #: TAK-875/OCT-002
• Secondary ID: U1111-1124-1561J
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2011
• Last updated: January 24, 2014
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1222
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• TAK-875

• TAK-875

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	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.	From Baseline to Week 53	Yes