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

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Diabetes, Type 2

Treatments: Drug: saxagliptin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857558

262-08-001

JapicCTI-090697 (Other Identifier)

Details and patient eligibility

About

A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes

Enrollment: 350 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes patients with HbA1c above 7.0% and below 10%
• 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

Exclusion criteria

• Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
• Patients with a medical history of diabetes coma
• Patients with poorly-controlled hypertension
• Patients with heart failure
• Patients with a complication of active hepatitis or hepatic cirrhosis
• Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy
• Patients with a history or complication of malignant tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

350 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

OPC-262 1mg

Treatment:

Drug: saxagliptin

Drug: saxagliptin

Drug: saxagliptin

2

Experimental group

Description:

OPC-262 2.5mg

Treatment:

Drug: saxagliptin

Drug: saxagliptin

Drug: saxagliptin

3

Experimental group

Description:

OPC-262 5mg

Treatment:

Drug: saxagliptin

Drug: saxagliptin

Drug: saxagliptin

4

Placebo Comparator group

Treatment:

Drug: placebo