A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes
Sponsor
Kyowa Kirin Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01193179
Collaborator
(none)
450
4
1
21
112.5
5.4
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
450 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus
Study Start Date
:
Jul 1, 2010
Actual Primary Completion Date
:
Apr 1, 2012
Actual Study Completion Date
:
Apr 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OPC-262
|
Drug: OPC-262
Oral administration of tablets for 52 weeks
|
Outcome Measures
Primary Outcome Measures
- Adverse events, clinical laboratory tests [52 weeks]
Secondary Outcome Measures
- Secondary Outcome HbA1c [52 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
- Patients who are capable of giving informed consent
-
- 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kanto Rigeon | Japan | |||
| 2 | Kinki Region | Japan | |||
| 3 | Kyushu Region | Japan | |||
| 4 | Tohoku Region | Japan |
Sponsors and Collaborators
- Kyowa Kirin Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01193179
Other Study ID Numbers:
- 262-10-005
- JapicCTI-101252
First Posted:
Sep 1, 2010
Last Update Posted:
Jan 8, 2014
Last Verified:
Jan 1, 2014