Along-term 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:
NCT01634282
First received: July 2, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in HBA1c form baseline [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-262 Drug: OPC-262
Orally administered once daily

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24)
  • Patients who are capable of giving informed consent prior to participating in this clinical study
  • Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria:

  • Patients who withdrew from Study 262-09-001
  • Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001
  • Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study
  • Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001
  • Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study
  • Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
  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: NCT01634282

Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Kansai Region, Japan
Kanto Region, Japan
Kyushu Region, Japan
Shikoku 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: NCT01634282     History of Changes
Other Study ID Numbers: 262-09-002
Study First Received: July 2, 2012
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 August 28, 2014