NCT01634282

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

July 2, 2012

Last Update Submit

January 6, 2014

Conditions

Diabetes, Type 2

Outcome Measures

Primary Outcomes (2)

  • Change in HBA1c form baseline

    52 Weeks

  • Incidence and severity of adverse events

    52 Weeks

Study Arms (1)

OPC-262

EXPERIMENTAL
Drug: OPC-262

Interventions

OPC-262DRUG

Orally administered once daily

OPC-262

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 6, 2012

Study Start

August 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

JP(7)