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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: OPC-262

• Registration Number: NCT01046318
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

The purpose of this clinical study is to evaluate the safety and efficacy of OPC-262 5 mg in patients with type 2 diabetes by repeated administration orally for 52 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-11
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-06
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Type 2 diabetes patients with HbA1C above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination
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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OPC-262 5 mg	OPC-262	OPC-262 5 mg will be orally administered once daily fro 52 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)	each visit (OC) and Week 52 (LOCF)
Clinical laboratory tests	every 4 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF)	each visit (OC) and Week 52 (LOCF)