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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01193179
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : January 8, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetes, Type 2 Drug: OPC-262 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus
Study Start Date : July 2010
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: OPC-262 Drug: OPC-262
Oral administration of tablets for 52 weeks

Outcome Measures

Primary Outcome Measures :
  1. Adverse events, clinical laboratory tests [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Secondary Outcome HbA1c [ Time Frame: 52 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193179

Kanto Rigeon, Japan
Kinki Region, Japan
Kyushu Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01193179     History of Changes
Other Study ID Numbers: 262-10-005
JapicCTI-101252 ( Other Identifier: JAPIC )
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases