A Phase 3 Study of OPC-262 in patients with type 2 diabetes

A long-term study of OPC-262 in patients with type 2 diabetes

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220920

Enrollment

100

Registered

2009-11-19

Start date

2009-11-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with type 2 diabetes

Interventions

investigational material(s) Generic name etc : OPC-262 5 mg INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
HbA1C Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)	—

Secondary

Measure	Time frame
Fasting blood glucose (FBG) Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026