Double Blind Comparative Study of TAK-875

Phase 3

Completed

• Conditions: Diabetic Patients
• Interventions: Drug: TAK-875; Drug: Placebo; Drug: Glimepiride

• Registration Number: NCT01585792
• 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: 2012-04-24
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Study Start: 2012-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• The participant is an outpatient.
• 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

• The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
• The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAK-875 25 mg	TAK-875	-
TAK-875 50 mg	TAK-875	-
Placebo	Placebo	-
Glimepiride	Glimepiride	-

Primary Outcome Measures

Name	Time	Method
Blood glucose	4 weeks	Blood glucose