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

January 6, 2014 updated by: Kyowa Kirin Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu Region, Japan
      • Kanto Region, Japan
      • Tohoku Region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 diabetes patients with HbA1C above 6.5% and below 10% at both of the time of the 1st and the 2nd screening examinations and who have been undergoing diet and exercise therapies only for at least 8 weeks prior to the 1st screening examination
  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 for the entire study period and for 4 weeks after the study (end of the post-observation period)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OPC-262 5 mg
OPC-262 5 mg will be orally administered once daily fro 52 weeks.
Drug: OPC-262
OPC-262 5 mg will be orally administered once daily fro 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)
Time Frame: each visit (OC) and Week 52 (LOCF)
each visit (OC) and Week 52 (LOCF)
Clinical laboratory tests
Time Frame: every 4 weeks
every 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in fasting blood glucose (FBG) from baseline to each visit (OC) and Week 52 (LOCF)
Time Frame: each visit (OC) and Week 52 (LOCF)
each visit (OC) and Week 52 (LOCF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 7, 2010

First Posted (ESTIMATE)

January 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262-09-004
  • JapicCTI-090952 (REGISTRY: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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