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

Diabetes Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997282
• Other study ID #: 262-09-001
• Secondary ID: JapicCTI-090904
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 16, 2009
• Last updated: January 6, 2014
• Start date: September 2009
• Est. completion date: October 2010

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 superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• 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%

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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• OPC-262 2.5 mg
orally administered once daily for 24 weeks
• OPC-262 5 mg
orally administered once daily for 24 weeks
• Placebo
orally administered once daily for 24 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		Week 24 (LOCF)	No
Secondary	Changes in fasting blood glucose (FBG) from baseline		Week 24	No
Secondary	Changes in 2 hour postprandial blood glucose (PPG) from baseline		Week 24	No
Secondary	Changes in 3 hour PPG AUC from baseline		Week 24	No