Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

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Detailed Description

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This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TA-7284-Low

Group Type EXPERIMENTAL

TA-7284-Low

Intervention Type DRUG

TA-7284-Low

TA-7284-High

Group Type EXPERIMENTAL

TA-7284-High

Intervention Type DRUG

TA-7284-High

Interventions

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TA-7284-Low

Intervention Type DRUG

TA-7284-High

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women age ≥20 years old
* Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
* HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
* HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

Exclusion Criteria

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
* Past or current history of severe diabetic complications
* Fasting plasma glucose \> 270 mg/dL before treatment start
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients requiring insulin therapy

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No