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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01193179
First received: August 30, 2010
Last updated: January 6, 2014
Last verified: January 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Adverse events, clinical laboratory tests [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary Outcome HbA1c [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193179

Locations
Japan
Kanto Rigeon, Japan
Kinki Region, Japan
Kyushu Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01193179     History of Changes
Other Study ID Numbers: 262-10-005, JapicCTI-101252
Study First Received: August 30, 2010
Last Updated: January 6, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 22, 2014