Long-term Study of SYR-472

An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01431807

Enrollment

680

Registered

2011-09-12

Start date

2011-09-01

Completion date

2013-06-01

Last updated

2023-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

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

Interventions

DRUGSYR-472

oral, for up to 52 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Adverse events	52 weeks.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026