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

NCT ID: NCT01046318

Last Updated: 2014-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OPC-262 5 mg

OPC-262 5 mg will be orally administered once daily fro 52 weeks.

Group Type EXPERIMENTAL

OPC-262

Intervention Type DRUG

OPC-262 5 mg will be orally administered once daily fro 52 weeks.

Interventions

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OPC-262

OPC-262 5 mg will be orally administered once daily fro 52 weeks.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chubu Region, , Japan

Site Status

Kanto Region, , Japan

Site Status

Tohoku Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JapicCTI-090952

Identifier Type: REGISTRY

Identifier Source: secondary_id

262-09-004

Identifier Type: -

Identifier Source: org_study_id

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