Double-blind Comparative Study of TAK-875

Phase 3

Completed

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

• Registration Number: NCT01433393
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 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
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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	-
TAK-875 50 mg	TAK-875	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
HbA1c