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

Phase 2

• Conditions: patients with type 2 diabetes

• Registration Number: JPRN-jRCT2080220672
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in HbA1C from baseline<br>2w, 4w, 8w, 12w

Secondary Outcome Measures

Name	Time	Method
values changes in HbA1C from baseline<br>2w, 4w, 8w, 12w