Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
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
1 other identifier
interventional
448
7 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Aug 2009
Typical duration for phase_2 type-2-diabetes-mellitus
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
September 1, 2014
CompletedJanuary 7, 2026
December 1, 2025
1.7 years
September 1, 2009
August 21, 2014
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to 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 Outcomes (2)
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
Baseline and Week 24
Adverse Events, Laboratory Tests, Vital Signs, Etc.
Weeks 24, 52
Study Arms (5)
MP-513 Lowest Dose and Metformin
EXPERIMENTALMP-513 Low Dose and Metformin
EXPERIMENTALMP-513 Medium Dose and Metformin
EXPERIMENTALMP-513 High Dose and Metformin
EXPERIMENTALPlacebo and Metformin
PLACEBO COMPARATORInterventions
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Aalborg, Denmark
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Ballerup Municipality, Denmark
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Vejle, Denmark
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Falkensee, Germany
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Hamburg, Germany
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Karlsruhe, Germany
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Kiel, Germany
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Ludwigshafen, Germany
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Lübeck, Germany
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Mainz, Germany
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Ádám, Hungary
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Békéscsaba, Hungary
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Budapest, Hungary
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Gyöngyös, Hungary
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Kaposvár, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Semmelweis, Hungary
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Szentes, Hungary
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Szigetvár, Hungary
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Gdansk, Poland
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Krakow, Poland
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Leszno, Poland
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Lodz, Poland
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Niemodlin, Poland
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Płock, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Brasov, Romania
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Bucharest, Romania
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Galati, Romania
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Ploieşti, Romania
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Timișoara, Romania
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Timuș, Romania
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Addlestone, United Kingdom
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Ayr, United Kingdom
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Bournemouth, United Kingdom
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East Sussex, United Kingdom
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Edinburgh, United Kingdom
Unknown Facility
Oldham, United Kingdom
Unknown Facility
York, United Kingdom
Related Publications (1)
Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 10.
PMID: 24205974DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
David Kerr, Dr
Royal Bournemouth Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 3, 2009
Study Start
August 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
January 7, 2026
Results First Posted
September 1, 2014
Record last verified: 2025-12