NCT00997282
Completed
Phase 2
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)
ConditionsDiabetes Type 2
Overview
- Phase
- Phase 2
- Intervention
- OPC-262 2.5 mg
- Conditions
- Diabetes Type 2
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 255
- Primary Endpoint
- Changes in HbA1C from baseline
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
OPC-262 2.5 mg
orally administered once daily for 24 weeks
Intervention: OPC-262 2.5 mg
OPC-262 5 mg
orally administered once daily for 24 weeks
Intervention: OPC-262 5 mg
Placebo
orally administered once daily for 24 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Changes in HbA1C from baseline
Time Frame: Week 24 (LOCF)
Secondary Outcomes
- 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)
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