A Study of OPC-262 in Patients With Type 2 Diabetes
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)
2 other identifiers
interventional
255
1 country
7
Brief Summary
The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Shorter than P25 for phase_2
7 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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 16, 2009
CompletedFirst Posted
Study publicly available on registry
October 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJanuary 8, 2014
January 1, 2014
1.1 years
October 16, 2009
January 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in HbA1C from baseline
Week 24 (LOCF)
Secondary Outcomes (3)
Changes in fasting blood glucose (FBG) from baseline
Week 24
Changes in 2 hour postprandial blood glucose (PPG) from baseline
Week 24
Changes in 3 hour PPG AUC from baseline
Week 24
Study Arms (3)
OPC-262 2.5 mg
EXPERIMENTALorally administered once daily for 24 weeks
OPC-262 5 mg
EXPERIMENTALorally administered once daily for 24 weeks
Placebo
PLACEBO COMPARATORorally administered once daily for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes patients with HbA1C above 6.5% and below 10%
- 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 (7)
Unknown Facility
Chubu Region, Japan
Unknown Facility
Chugoku Region, Japan
Unknown Facility
Kansai Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Kyushu Region, Japan
Unknown Facility
Shikoku Region, Japan
Unknown Facility
Tohoku Region, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kaatsuhisa Saito
OPCJ
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2009
First Posted
October 19, 2009
Study Start
September 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
January 8, 2014
Record last verified: 2014-01