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

• Sponsor: Kyowa Kirin Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01634282
• Collaborator: (none)
• Enrollment: 222
• Locations: 7
• Arm: 1
• Duration (Months): 22
• Patients Per Site: 31.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262

Condition or Disease	Intervention/Treatment	Phase
Diabetes, Type 2	Drug: OPC-262	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 222 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPC-262	Drug: OPC-262; Orally administered once daily

Outcome Measures

Primary Outcome Measures

1. Change in HBA1c form baseline [52 Weeks]

2. Incidence and severity of adverse events [52 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24）

• Patients who are capable of giving informed consent prior to participating in this clinical study

• 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 who withdrew from Study 262-09-001

• Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001

• Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study

• Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001

• Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study

• Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chubu Region		Japan
2		Chugoku Region		Japan
3		Kansai Region		Japan
4		Kanto Region		Japan
5		Kyushu Region		Japan
6		Shikoku Region		Japan
7		Tohoku Region		Japan

Sponsors and Collaborators

• Kyowa Kirin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyowa Kirin Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01634282
• Other Study ID Numbers: 262-09-002
• First Posted: Jul 6, 2012
• Last Update Posted: Jan 8, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 8, 2014