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NCT01193179 Clinical Trial

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

Diabetes, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01193179
Other study ID # 262-10-005
Secondary ID JapicCTI-101252
Status Completed
Phase Phase 3
First received August 30, 2010
Last updated January 6, 2014
Start date July 2010
Est. completion date April 2012

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

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• OPC-262
Oral administration of tablets for 52 weeks

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 Adverse events, clinical laboratory tests 52 weeks Yes
Secondary Secondary Outcome HbA1c 52 weeks No
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