Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

NCT ID: NCT01413204

Last Updated: 2026-01-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

Detailed Description

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This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 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

TRIPLE

Participants Caregivers Investigators

Study Groups

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TA-7284 Low

Group Type EXPERIMENTAL

TA-7284 Low

Intervention Type DRUG

The patients will receive TA-7284-Low orally for 24 weeks.

TA-7284 High

Group Type EXPERIMENTAL

TA-7284 High

Intervention Type DRUG

The patients will receive TA-7284-High orally for 24 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The patients will receive Placebo orally for 24 weeks.

Interventions

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TA-7284 Low

The patients will receive TA-7284-Low orally for 24 weeks.

Intervention Type DRUG

TA-7284 High

The patients will receive TA-7284-High orally for 24 weeks.

Intervention Type DRUG

Placebo

The patients will receive Placebo orally for 24 weeks.

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 run-in period
* HbA1c of ≥7.0% and ≤10.0%

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

Sponsors

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Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nobuya Inagaki, M.D.

Role: STUDY_DIRECTOR

Kyoto University, Graduate School of Medicine

Kazuoki Kondo, M.D.

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

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Reserch site

Chūbu, , Japan

Site Status

Reserch site

Kanto, , Japan

Site Status

Reserch site

Kinki, , Japan

Site Status

Reserch site

Shikoku, , Japan

Site Status

Reserch site

Tōhoku, , Japan

Site Status

Countries

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Japan

References

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Inagaki N, Kondo K, Yoshinari T, Takahashi N, Susuta Y, Kuki H. Efficacy and safety of canagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled with diet and exercise: a 24-week, randomized, double-blind, placebo-controlled, Phase III study. Expert Opin Pharmacother. 2014 Aug;15(11):1501-15. doi: 10.1517/14656566.2014.935764.

Reference Type DERIVED
PMID: 25010793 (View on PubMed)

Other Identifiers

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TA-7284-05

Identifier Type: -

Identifier Source: org_study_id

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