Along-term Study of OPC-262 in Patients With Type 2 Diabetes

Diabetes, Type 2 Clinical Trial

Official title:

A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634282
• Other study ID #: 262-09-002
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2012
• Last updated: January 6, 2014
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2014
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24)

• Patients who are capable of giving informed consent prior to participating in this clinical study

• Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria:

• Patients who withdrew from Study 262-09-001

• Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001

• Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study

• Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001

• Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study

• Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes, Type 2

Intervention

Drug:
• OPC-262
Orally administered once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HBA1c form baseline		52 Weeks	No
Primary	Incidence and severity of adverse events		52 Weeks	Yes