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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kyowa Hakko Kirin Co., Ltd

ClinicalTrials.gov Identifier:

NCT01046318

First received: January 6, 2010

Last updated: January 6, 2014

Last verified: January 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: OPC-262	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Long-term Study of OPC-262 in Patients With Type 2 Diabetes

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:

Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF) [ Time Frame: each visit (OC) and Week 52 (LOCF) ]
Clinical laboratory tests [ Time Frame: every 4 weeks ]

Secondary Outcome Measures:

Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF) [ Time Frame: each visit (OC) and Week 52 (LOCF) ]


Enrollment:	100
Study Start Date:	November 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OPC-262 5 mg OPC-262 5 mg will be orally administered once daily fro 52 weeks.	Drug: OPC-262 OPC-262 5 mg will be orally administered once daily fro 52 weeks.

Eligibility


Ages Eligible for Study:	20 Years to 74 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046318

Locations


Japan

Chubu Region, Japan

Kanto Region, Japan

Tohoku Region, Japan

Sponsors and Collaborators

Kyowa Hakko Kirin Co., Ltd

More Information


Responsible Party:	Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:	NCT01046318 History of Changes
Other Study ID Numbers:	262-09-004 JapicCTI-090952 ( Registry Identifier: JAPIC )
Study First Received:	January 6, 2010
Last Updated:	January 6, 2014

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on June 22, 2017

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