Status:
COMPLETED
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Diabetes, Type 2
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes
Eligibility Criteria
Inclusion
- Type 2 diabetes patients with HbA1c above 7.0% 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
Exclusion
- Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
- Patients with a medical history of diabetes coma
- Patients with poorly-controlled hypertension
- Patients with heart failure
- Patients with a complication of active hepatitis or hepatic cirrhosis
- Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy
- Patients with a history or complication of malignant tumor
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00857558
Start Date
January 1 2009
End Date
May 1 2010
Last Update
March 9 2017
Active Locations (8)
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1
Chubu Regin, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan