Double-blind Comparative Study of SYR-472

Takeda

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: SYR-472; Drug: Placebo; Drug: Alogliptin 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01632007

JapicCTI-121839 (Registry Identifier)

SYR-472/CCT-002

U1111-1128-6104 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.

Enrollment: 245 estimated 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.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
2. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Trial design

245 participants in 3 patient groups, including a placebo group

SYR-472 100 mg

Experimental group

Treatment:

Drug: SYR-472

Alogliptin 25 mg

Active Comparator group

Treatment:

Drug: Alogliptin 25 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo