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

Phase 3

Completed

• Conditions: Diabetes, Type 2
• Interventions: Drug: OPC-262

• Registration Number: NCT01193179
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-06
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OPC-262	OPC-262	-

Primary Outcome Measures

Name	Time	Method
Adverse events, clinical laboratory tests	52 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome HbA1c	52 weeks