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

Kyowa Kirin

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Type 2

Treatments: Drug: Placebo; Drug: OPC-262 5 mg; Drug: OPC-262 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00997282

JapicCTI-090904

262-09-001

Details and patient eligibility

About

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.

Enrollment: 255 estimated patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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255 participants in 3 patient groups, including a placebo group

OPC-262 2.5 mg

Experimental group

Description:

orally administered once daily for 24 weeks

Treatment:

Drug: OPC-262 2.5 mg

OPC-262 5 mg

Experimental group

Description:

orally administered once daily for 24 weeks

Treatment:

Drug: OPC-262 5 mg

Placebo

Placebo Comparator group

Description:

orally administered once daily for 24 weeks

Treatment:

Drug: Placebo