Double Blind Comparative Study of TAK-875

Takeda

Status and phase: Completed; Phase 3

Conditions: Diabetic Patients

Treatments: Drug: TAK-875; Drug: Glimepiride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01585792

TAK-875/CPH-030

U1111-1129-7907 (Registry Identifier)

JapicCTI-121816 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 4 patient groups, including a placebo group

TAK-875 25 mg

Experimental group

Treatment:

Drug: TAK-875

Drug: TAK-875

TAK-875 50 mg

Experimental group

Treatment:

Drug: TAK-875

Drug: TAK-875

Glimepiride

Active Comparator group

Treatment:

Drug: Glimepiride

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo