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

This study has been completed.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd Identifier:
First received: August 30, 2010
Last updated: January 6, 2014
Last verified: January 2014
The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent

Condition Intervention Phase
Diabetes, Type 2 Drug: OPC-262 Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

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

Secondary Outcome Measures:
  • Secondary Outcome HbA1c [ Time Frame: 52 weeks ]

Estimated Enrollment: 450
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-262 Drug: OPC-262
Oral administration of tablets for 52 weeks


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
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Please refer to this study by its identifier: 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 Identifier: NCT01193179     History of Changes
Other Study ID Numbers: 262-10-005
JapicCTI-101252 ( Other Identifier: JAPIC )
Study First Received: August 30, 2010
Last Updated: January 6, 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 21, 2017