A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes

The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent

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Key information

Conditions

Diabetes, Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kanto Rigeon, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1) Patients who are capable of giving informed consent
2) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion criteria

Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus

Treatment and study plan

OPC-262

Drug

Oral administration of tablets for 52 weeks

Primary outcomes

Adverse events, clinical laboratory tests

Time frame: 52 weeks

Secondary outcomes

Secondary Outcome HbA1c

Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Long-term Co-administration Study of OPC-262 in Patients With Type 2 Diabetes Mellitus

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Sep 1, 2010
Registry last updated: Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed