A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes

Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01193179

Enrollment

450

Registered

2010-09-01

Start date

2010-07-31

Completion date

2012-04-30

Last updated

2014-01-08

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

Conditions

Diabetes, Type 2

Brief summary

The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent

Interventions

DRUGOPC-262

Oral administration of tablets for 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\) Patients who are capable of giving informed consent * 2\) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion criteria

* Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Adverse events, clinical laboratory tests	52 weeks

Secondary

Measure	Time frame
Secondary Outcome HbA1c	52 weeks

Countries

Japan

Outcome results

None listed

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