A Study of OPC-262 in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Type 2
• Interventions: Drug: OPC-262 2.5 mg; Drug: OPC-262 5 mg; Drug: Placebo

• Registration Number: NCT00997282
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-06
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

1. Type 2 diabetes patients with HbA1C above 6.5% and below 10%
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

1. Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPC-262 2.5 mg	OPC-262 2.5 mg	orally administered once daily for 24 weeks
OPC-262 5 mg	OPC-262 5 mg	orally administered once daily for 24 weeks
Placebo	Placebo	orally administered once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Changes in HbA1C from baseline	Week 24 (LOCF)

Secondary Outcome Measures

Name	Time	Method
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