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Completed

NCT Number: NCT01634282

Along-term Study of OPC-262 in Patients With Type 2 Diabetes

The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262

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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–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24）
  • Patients who are capable of giving informed consent prior to participating in this clinical study
  • Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion criteria

  • Patients who withdrew from Study 262-09-001
  • Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001
  • Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study
  • Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001
  • Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study
  • Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Treatment and study plan

OPC-262

Drug

Orally administered once daily

Primary outcomes

  1. Change in HBA1c form baseline

    Time frame: 52 Weeks

  2. Incidence and severity of adverse events

    Time frame: 52 Weeks

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 6, 2012
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.

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