Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes
NCT ID: NCT02220907
Last Updated: 2026-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
153 participants
INTERVENTIONAL
2014-08-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Teneligliptin/Canagliflozin
Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.
Teneligliptin/Canagliflozin
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
Interventions
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Teneligliptin/Canagliflozin
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c of ≥7.0% and \<10.5%
* FPG of ≤ 270 mg/dL
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period
Exclusion Criteria
* Patients with serious diabetic complications
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with severe hepatic disorder or severe renal disorder.
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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Takashi Kadowaki, MD
Role: STUDY_DIRECTOR
Tokyo University
Nobuya Inagaki, MD
Role: STUDY_DIRECTOR
Kyoto University
Kazuoki Kondo, MD
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Research site
Chugoku, , Japan
Research site
Chūbu, , Japan
Research site
Hokkaido, , Japan
Research site
Kanto, , Japan
Research site
Kyushu, , Japan
Research site
Tōhoku, , Japan
Countries
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References
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Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31.
Other Identifiers
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MT-2412-J01
Identifier Type: -
Identifier Source: org_study_id
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