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New diabetes combo drug shows promise in early trial

NCT ID NCT00971243

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested four different doses of a new drug called MP-513 in 448 adults with type 2 diabetes who were already taking metformin. The goal was to see which dose works best and is safe for lowering blood sugar over 24 weeks, with an extension up to 52 weeks. Participants took MP-513 tablets once daily alongside their usual metformin.

What this could mean

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

Active substance
MP-513 (a diabetes drug) plus metformin
What this could lead to
If successful, this could provide a new treatment option for people with type 2 diabetes to better control their blood sugar when metformin alone isn't enough.
What could go wrong
This is an early phase II dose-finding study, so the drug may not prove effective or safe enough for approval. Side effects are still being evaluated.

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

448 people

The number who actually took part.

Start date

Aug 2009

Finished

Apr 2011

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

18 years and older

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 aged ≧ 18 years old. * Patients whose HbA1c is ≧ 7.0 % and \< 10.0%. * Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡. * Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit. Exclusion Criteria: * Patients with type 1 diabetes or secondary form of diabetes. * Patients with heart failure symptoms. * Patients with serious diabetic complications. * Patients with severe hepatic disorder or severe renal disorder. * Patients who are the excessive alcohol addicts. * 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.

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 mellitus

Contacts and locations

Locations

  • Study site

    Aalborg, Denmark

  • Study site

    Ballerup Municipality, Denmark

  • Study site

    Vejle, Denmark

  • Study site

    Falkensee, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Karlsruhe, Germany

  • Study site

    Kiel, Germany

  • Study site

    Ludwigshafen, Germany

  • Study site

    Lübeck, Germany

  • Study site

    Mainz, Germany

  • Study site

    Ádám, Hungary

  • Study site

    Békéscsaba, Hungary

  • Study site

    Budapest, Hungary

  • Study site

    Gyöngyös, Hungary

  • Study site

    Kaposvár, Hungary

  • Study site

    Miskolc, Hungary

  • Study site

    Nyíregyháza, Hungary

  • Study site

    Semmelweis, Hungary

  • Study site

    Szentes, Hungary

  • Study site

    Szigetvár, Hungary

  • Study site

    Kaunas, Lithuania

  • Study site

    Klaipėda, Lithuania

  • Study site

    Vilnius, Lithuania

  • Study site

    Gdansk, Poland

  • Study site

    Krakow, Poland

  • Study site

    Leszno, Poland

  • Study site

    Lodz, Poland

  • Study site

    Niemodlin, Poland

  • Study site

    Płock, Poland

  • Study site

    Warsaw, Poland

  • Study site

    Wroclaw, Poland

  • Study site

    Brasov, Romania

  • Study site

    Bucharest, Romania

  • Study site

    Galati, Romania

  • Study site

    Ploieşti, Romania

  • Study site

    Timișoara, Romania

  • Study site

    Timuș, Romania

  • Study site

    Addlestone, United Kingdom

  • Study site

    Ayr, United Kingdom

  • Study site

    Bournemouth, United Kingdom

  • Study site

    East Sussex, United Kingdom

  • Study site

    Edinburgh, United Kingdom

  • Study site

    Oldham, United Kingdom

  • Study site

    York, United Kingdom

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