Long-term Study of TAK-875

Takeda

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: TAK-875

Study type: Interventional

Funder types: Industry

Identifiers

NCT01433406

U1111-1124-1561 (Registry Identifier)

JapicCTI-111602 (Registry Identifier)

TAK-875/OCT-002

Details and patient eligibility

About

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

Enrollment: 1,222 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

1,222 participants in 2 patient groups

TAK-875 25 mg

Experimental group

Description:

(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)

Treatment:

Drug: TAK-875

Drug: TAK-875

TAK-875 50 mg

Experimental group

Description:

(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)

Treatment:

Drug: TAK-875

Drug: TAK-875