Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus
NCT ID: NCT01072331
Last Updated: 2026-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
99 participants
INTERVENTIONAL
2010-02-28
2010-08-31
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
QUADRUPLE
Study Groups
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MP-513 10 mg, once a day, for 4 weeks
MP-513
MP-513 10 mg, once a day, for 4 weeks
MP-513 20 mg, once a day, for 4 weeks
MP-513
MP-513 20 mg, once a day, for 4 weeks
Placebo of MP-513
Placebo of MP-513
MP-513 placebo, once a day, for 4 weeks
Interventions
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MP-513
MP-513 10 mg, once a day, for 4 weeks
MP-513
MP-513 20 mg, once a day, for 4 weeks
Placebo of MP-513
MP-513 placebo, once a day, for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
* Patients whose HbA1c is ≥6.5% and \<10.0%
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 weeks before administration of investigational drug.
Exclusion Criteria
* Patients who are accepting treatments of arrhythmias
* Patients with serious diabetic complications
* Patients who are the excessive alcohol addicts
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
20 Years
75 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kazuoki Kondo, MD
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Tadashi Yoshida, MD
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Suita, Osaka, Japan
Countries
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References
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Eto T, Inoue S, Kadowaki T. Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2012 Nov;14(11):1040-6. doi: 10.1111/j.1463-1326.2012.01662.x. Epub 2012 Jul 29.
Other Identifiers
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3000-A12
Identifier Type: -
Identifier Source: org_study_id
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