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

August 30, 2010
January 6, 2014
July 2010
April 2012   (final data collection date for primary outcome measure)
Adverse events, clinical laboratory tests [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01193179 on ClinicalTrials.gov Archive Site
Secondary Outcome HbA1c [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes
Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes, Type 2
Drug: OPC-262
Oral administration of tablets for 52 weeks
Experimental: OPC-262
Intervention: Drug: OPC-262
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01193179
262-10-005, JapicCTI-101252
No
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP