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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Saxagliptin

Criteria

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