Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes
NCT ID: NCT01413204
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
272 participants
INTERVENTIONAL
2011-07-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TA-7284 Low
TA-7284 Low
The patients will receive TA-7284-Low orally for 24 weeks.
TA-7284 High
TA-7284 High
The patients will receive TA-7284-High orally for 24 weeks.
Placebo
Placebo
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.
TA-7284 High
The patients will receive TA-7284-High orally for 24 weeks.
Placebo
The patients will receive Placebo orally for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period
* HbA1c of ≥7.0% and ≤10.0%
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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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
Reserch site
Kanto, , Japan
Reserch site
Kinki, , Japan
Reserch site
Shikoku, , Japan
Reserch site
Tōhoku, , Japan
Countries
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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.
Other Identifiers
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TA-7284-05
Identifier Type: -
Identifier Source: org_study_id
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