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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
August 30, 2010
September 1, 2010
January 8, 2014
July 2010
April 2012   (Final data collection date for primary outcome measure)
Adverse events, clinical laboratory tests [ Time Frame: 52 weeks ]
Same as current
Complete list of historical versions of study NCT01193179 on ClinicalTrials.gov Archive Site
Secondary Outcome HbA1c [ Time Frame: 52 weeks ]
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01193179
262-10-005
JapicCTI-101252 ( Other Identifier: JAPIC )
No
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin Co., Ltd
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
January 2014

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