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

Kyowa Kirin Co., Ltd.0 sites100 target enrollmentNovember 2009

ConditionsType 2 Diabetes

InterventionsOPC-262

DrugsOPC-262

Overview

Phase: Phase 3
Intervention: OPC-262
Conditions: Type 2 Diabetes
Sponsor: Kyowa Kirin Co., Ltd.
Enrollment: 100
Primary Endpoint: Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

July 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kyowa Kirin Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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