Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes

December 15, 2025 updated by: Tanabe Pharma Corporation

A Phase IIb, Double-blind, Parallel Group, Multi-center, Dose-finding Study to Investigate the Efficacy and Safety of 4 Doses of MP-513 When Added to Ongoing Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus, With an Open Label Extension

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

448

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
      • Ballerup Municipality, Denmark
      • Vejle, Denmark
  • Germany
      • Falkensee, Germany
      • Hamburg, Germany
      • Karlsruhe, Germany
      • Kiel, Germany
      • Ludwigshafen, Germany
      • Lübeck, Germany
      • Mainz, Germany
  • Hungary
      • Budapest, Hungary
      • Békéscsaba, Hungary
      • Gyöngyös, Hungary
      • Kaposvár, Hungary
      • Miskolc, Hungary
      • Nyíregyháza, Hungary
      • Semmelweis, Hungary
      • Szentes, Hungary
      • Szigetvár, Hungary
      • Ádám, Hungary
  • Lithuania
      • Kaunas, Lithuania
      • Klaipėda, Lithuania
      • Vilnius, Lithuania
  • Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Leszno, Poland
      • Lodz, Poland
      • Niemodlin, Poland
      • Płock, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
  • Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Galati, Romania
      • Ploieşti, Romania
      • Timișoara, Romania
      • Timuș, Romania
  • United Kingdom
      • Addlestone, United Kingdom
      • Ayr, United Kingdom
      • Bournemouth, United Kingdom
      • East Sussex, United Kingdom
      • Edinburgh, United Kingdom
      • Oldham, United Kingdom
      • York, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MP-513 Lowest Dose and Metformin
Drug: MP-513 Lowest Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Experimental: MP-513 Low Dose and Metformin
Drug: MP-513 Low Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Experimental: MP-513 Medium Dose and Metformin
Drug: MP-513 Medium Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Experimental: MP-513 High Dose and Metformin
Drug: MP-513 High Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Placebo Comparator: Placebo and Metformin
Drug: Placebo and Metformin
Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 24
Time Frame: Baseline and Week 24
The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
Time Frame: Baseline and Week 24
Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.
Baseline and Week 24
Adverse Events, Laboratory Tests, Vital Signs, Etc.
Time Frame: Weeks 24, 52
Weeks 24, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma Corporation

Investigators

  • Principal Investigator: David Kerr, Dr, Royal Bournemouth Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimated)

September 3, 2009

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-513-E07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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