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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046318
• Other study ID #: 262-09-004
• Secondary ID: JapicCTI-090952
• Status: Completed
• Phase: Phase 3
• First received: January 6, 2010
• Last updated: January 6, 2014
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2014
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• OPC-262
OPC-262 5 mg will be orally administered once daily fro 52 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)		each visit (OC) and Week 52 (LOCF)	No
Primary	Clinical laboratory tests		every 4 weeks	Yes
Secondary	Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF)		each visit (OC) and Week 52 (LOCF)	No