Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
255 participants
INTERVENTIONAL
2009-09-30
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Along-term Study of OPC-262 in Patients With Type 2 Diabetes
NCT01634282
A Study of OPC-262 in Patients With Type 2 Diabetes
NCT01046318
A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes
NCT01193179
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
NCT00857558
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
NCT04552470
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OPC-262 2.5 mg
orally administered once daily for 24 weeks
OPC-262 2.5 mg
orally administered once daily for 24 weeks
OPC-262 5 mg
orally administered once daily for 24 weeks
OPC-262 5 mg
orally administered once daily for 24 weeks
Placebo
orally administered once daily for 24 weeks
Placebo
orally administered once daily for 24 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OPC-262 2.5 mg
orally administered once daily for 24 weeks
OPC-262 5 mg
orally administered once daily for 24 weeks
Placebo
orally administered once daily for 24 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients who are capable of giving informed consent
3. 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
2. Patients with a medical history of diabetic coma
3. Patients with poorly-controlled hypertension
4. Patients with heart failure
5. Patients with a complication of active hepatitis or hepatic cirrhosis
6. Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
7. Patients with a history or complication of malignant tumor
20 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kaatsuhisa Saito
Role: STUDY_CHAIR
OPCJ
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chubu Region, , Japan
Chugoku Region, , Japan
Kansai Region, , Japan
Kanto Region, , Japan
Kyushu Region, , Japan
Shikoku Region, , Japan
Tohoku Region, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JapicCTI-090904
Identifier Type: -
Identifier Source: secondary_id
262-09-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.