New diabetes pill shows promise in year-long safety trial
NCT ID NCT02314637
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the long-term safety and blood sugar control of the drug MP-513 (Teneligliptin) in 240 Japanese adults with type 2 diabetes. Some participants took MP-513 alone, while others took it together with another diabetes medicine called glimepiride. The study lasted 52 weeks and tracked side effects and changes in blood sugar levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
240 people
The number who actually took part.
- Start date
-
Aug 2009
- Finished
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Jul 2011
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea for diabetes over 12 weeks before administration of investigational drug * Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * HbA1c criteria: * monotherapy: 6.9% - 10.5% * combination therapy with Sulfonylurea: 7.4 - 10.5% * Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug. Exclusion Criteria: * Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Reserch site
Shikoku, Japan
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Other studies related to the condition(s) this trial covers.
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