A Study of OPC-262 in Patients With Type 2 Diabetes
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01046318 |
Recruitment Status
:
Completed
First Posted
: January 11, 2010
Last Update Posted
: January 8, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: OPC-262 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Long-term Study of OPC-262 in Patients With Type 2 Diabetes |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
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.
|
- 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 ]
- 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) ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 74 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046318
Japan | |
Chubu Region, Japan | |
Kanto Region, Japan | |
Tohoku Region, Japan |
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 ) |
First Posted: | January 11, 2010 Key Record Dates |
Last Update Posted: | January 8, 2014 |
Last Verified: | January 2014 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |