A Study of OPC-262 in Patients With Type 2 Diabetes
A Long-term Study of OPC-262 in Patients With Type 2 Diabetes
2 other identifiers
interventional
100
1 country
3
Brief Summary
The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in patients with type 2 diabetes by repeated administration orally for 52 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes
Started Nov 2009
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJanuary 8, 2014
January 1, 2014
1.7 years
January 6, 2010
January 6, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)
each visit (OC) and Week 52 (LOCF)
Clinical laboratory tests
every 4 weeks
Secondary Outcomes (1)
Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF)
each visit (OC) and Week 52 (LOCF)
Study Arms (1)
OPC-262 5 mg
EXPERIMENTALOPC-262 5 mg will be orally administered once daily fro 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes patients with HbA1C above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination
- 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 for the entire study period and for 4 weeks after the study (end of the post-observation period)
You may not qualify if:
- Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
- Patients with a medical history of diabetic coma
- Patients with poorly-controlled hypertension
- Patients with heart failure
- Patients with a complication of active hepatitis or hepatic cirrhosis
- Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
- Patients with a history or complication of malignant tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Chubu Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Tohoku Region, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2010
First Posted
January 11, 2010
Study Start
November 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
January 8, 2014
Record last verified: 2014-01