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New diabetes pill shows promise in early trial

NCT ID NCT00628212

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested a new drug called teneligliptin (MP-513) in 324 Japanese adults with type 2 diabetes. Participants took one of three doses of the drug or a placebo daily for 12 weeks. The main goal was to see how well the drug lowered blood sugar levels (HbA1c) and to check for side effects. The results will help determine the right dose for larger, confirmatory studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Teneligliptin (also called MP-513), a drug taken once daily to lower blood sugar
What this could lead to
If successful, this could provide a new once-daily pill option to help control blood sugar in people with type 2 diabetes.
What could go wrong
This is an early-phase trial with only 324 participants over 12 weeks. Long-term safety and effectiveness are not yet known, and results may not apply to non-Japanese populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

324 people

The number who actually took part.

Start date

Jan 2008

Finished

Jan 2009

Lead sponsor

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who are 20 - 75 years old * Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * Patients whose HbA1c is 6.5 - 9.5% * Patients who were not administered 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 failure, or secondary diabetes (Cushing disease, acromegaly, etc) * Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification * Patients with serious diabetic complications * Patients who are habitual excessive alcohol consumption. * Patients with severe hepatic disorder or severe renal disorder. * 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.

Insulin Resistance type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

  • Study site

    Takikawa-shi, Hokkaido, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.