Long-term Study of TAK-875

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: TAK-875

• Registration Number: NCT01433406
• Lead Sponsor: Takeda

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-14
• Study Start: 2011-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-24
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1222

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-875 25 mg	TAK-875	(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
TAK-875 50 mg	TAK-875	(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)

Primary Outcome Measures

Name	Time	Method
Adverse events	From Baseline to Week 53	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.