Status:
COMPLETED
A Study of OPC-262 in Patients With Type 2 Diabetes
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Diabetes Type 2
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
PHASE3
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 fa...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00997282
Start Date
September 1 2009
End Date
October 1 2010
Last Update
January 8 2014
Active Locations (7)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Kansai Region, Japan
4
Kanto Region, Japan