Back to resultsAlong-term Study of OPC-262 in Patients With Type 2 Diabetes
Primary Purpose
Diabetes, Type 2
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OPC-262
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes, Type 2
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OPC-262
Arm Description
Outcomes
Primary Outcome Measures
Change in HBA1c form baseline
Incidence and severity of adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01634282
Brief Title
Along-term Study of OPC-262 in Patients With Type 2 Diabetes
Official Title
A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPC-262
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OPC-262
Intervention Description
Orally administered once daily
Primary Outcome Measure Information:
Title
Change in HBA1c form baseline
Time Frame
52 Weeks
Title
Incidence and severity of adverse events
Time Frame
52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Kansai Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Shikoku Region
Country
Japan
City
Tohoku Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Along-term Study of OPC-262 in Patients With Type 2 Diabetes
We'll reach out to this number within 24 hrs