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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01193179
First Posted: September 1, 2010
Last Update Posted: January 8, 2014
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.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  Purpose
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Locations
Japan
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 Submitted: August 30, 2010
First Posted: September 1, 2010
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