Long-term Study of SYR-472

Takeda

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: SYR-472

Study type: Interventional

Funder types: Industry

Identifiers

NCT01431807

U1111-1123-6415 (Registry Identifier)

JapicCTI-111592 (Registry Identifier)

SYR-472/OCT-001

Details and patient eligibility

About

To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.

Enrollment: 680 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.
3. Diabetes Mellitus

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 subinvestigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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680 participants in 1 patient group

SYR-472 group

Experimental group

Description:

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

Treatment:

Drug: SYR-472