Double-blind Comparative Study of TAK-875

Takeda

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: TAK-875; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01433393

U1111-1124-1518 (Registry Identifier)

JapicCTI-111604 (Registry Identifier)

TAK-875/CCT-003

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: 192 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

192 participants in 3 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

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo