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

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Diabetes, Type 2

Treatments: Drug: OPC-262

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193179

JapicCTI-101252 (Other Identifier)

262-10-005

Details and patient eligibility

About

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

Enrollment: 450 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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450 participants in 1 patient group

OPC-262

Experimental group

Treatment:

Drug: OPC-262