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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014