Type 2 Diabetes MellitusPhase 2NCT00971243

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

A Phase 2 study testing MP-513 Lowest Dose and Metformin, MP-513 Low Dose and Metformin and MP-513 Medium Dose and Metformin in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 44 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: MP-513 Lowest Dose and Metformin, MP-513 Low Dose and Metformin and MP-513 Medium Dose and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 448 participants
Where: 44 sitesin 7 countries
Study dates: Aug 2009to Apr 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

44 sites in 7 countries.

Country

City, postcode or hospital

44 sites in 7 countries

Hungary10 sites

Study site
Ádám
Study site
Békéscsaba
Study site
Budapest
Study site
Gyöngyös
Study site
Kaposvár
Study site
Miskolc
Study site
Nyíregyháza
Study site
Semmelweis
Study site
Szentes
Study site
Szigetvár

Other trials in Hungary

Poland8 sites

Study site
Gdansk
Study site
Krakow
Study site
Leszno
Study site
Lodz
Study site
Niemodlin
Study site
Płock
Study site
Warsaw
Study site
Wroclaw

Other trials in Poland

Germany7 sites

Study site
Falkensee
Study site
Hamburg
Study site
Karlsruhe
Study site
Kiel
Study site
Lübeck
Study site
Ludwigshafen
Study site
Mainz

Other trials in Germany

United Kingdom7 sites

Study site
Addlestone
Study site
Ayr
Study site
Bournemouth
Study site
East Sussex
Study site
Edinburgh
Study site
Oldham
Study site
York

Other trials in United Kingdom

Romania6 sites

Study site
Brasov
Study site
Bucharest
Study site
Galati
Study site
Ploieşti
Study site
Timișoara
Study site
Timuș

Other trials in Romania

Denmark3 sites

Study site
Aalborg
Study site
Ballerup Municipality
Study site
Vejle

Other trials in Denmark

Lithuania3 sites

Study site
Kaunas
Study site
Klaipėda
Study site
Vilnius

Other trials in Lithuania

About this study

Official title: 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

Conditions: Type 2 Diabetes Mellitus
Being tested: MP-513 Lowest Dose and Metformin, MP-513 Low Dose and Metformin, MP-513 Medium Dose and Metformin, MP-513 High Dose and Metformin, Placebo and Metformin
Keywords: Insulin resistance
Medical subject headings: Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MP-513 Lowest Dose and MetforminDrug
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 Low Dose and MetforminDrug
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 Medium Dose and MetforminDrug
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
MP-513 High Dose and MetforminDrug
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Placebo and MetforminDrug
Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

Study groups in NCT00971243
Study group	Role	What they receive
MP-513 Lowest Dose and Metformin	Experimental	Not described Receives: Drug: MP-513 Lowest Dose and Metformin
MP-513 Low Dose and Metformin	Experimental	Not described Receives: Drug: MP-513 Low Dose and Metformin
MP-513 Medium Dose and Metformin	Experimental	Not described Receives: Drug: MP-513 Medium Dose and Metformin
MP-513 High Dose and Metformin	Experimental	Not described Receives: Drug: MP-513 High Dose and Metformin
Placebo and Metformin	Placebo comparator	Not described Receives: Drug: Placebo and Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 24

Secondary outcomes (2)

Change in Fasting Plasma Glucose (FPG) From Baseline to 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.
Measured: Baseline and Week 24
Adverse Events, Laboratory Tests, Vital Signs, Etc.
Measured: Weeks 24, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Apr 2011

First posted3 Sep 2009 (estimated)
Study startAug 2009
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 448 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00971243
Sponsor's protocol ID: MP-513-E07
Status last verified: Dec 2025
First submitted: 1 Sep 2009
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 24205974

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00971243
Acronym / sponsor ID: MP-513-E07
Conditions: Type 2 Diabetes Mellitus
Keywords: Insulin resistance
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 448 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 3 Sep 2009 (estimated)
Results: Posted 1 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
MP-513 Lowest Dose and Metformin	Experimental	Drug: MP-513 Lowest Dose and Metformin
MP-513 Low Dose and Metformin	Experimental	Drug: MP-513 Low Dose and Metformin
MP-513 Medium Dose and Metformin	Experimental	Drug: MP-513 Medium Dose and Metformin
MP-513 High Dose and Metformin	Experimental	Drug: MP-513 High Dose and Metformin
Placebo and Metformin	Placebo comparator	Drug: Placebo and Metformin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MP-513 Lowest Dose and MetforminMP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.	Drug	MP-513 Lowest Dose and Metformin
MP-513 Low Dose and MetforminMP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.	Drug	MP-513 Low Dose and Metformin
MP-513 Medium Dose and MetforminMP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.	Drug	MP-513 Medium Dose and Metformin
MP-513 High Dose and MetforminMP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.	Drug	MP-513 High Dose and Metformin
Placebo and MetforminPlacebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.	Drug	Placebo and Metformin

Primary outcome

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.

2 secondary outcomes

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
Time frame: Baseline and Week 24
Adverse Events, Laboratory Tests, Vital Signs, Etc.
Time frame: Weeks 24, 52

Results and safety

Results posted to the registry on 1 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teneli 5mg+Met	87	68
Teneli 10mg+Met	93	82
Teneli 20mg+Met	91	72
Teneli 40mg+Met	88	74
Placebo+Met	88	70

Primary outcome: Change in HbA1c From Baseline to Week 24

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	Teneli 5mg+Met n = 87	Teneli 10mg+Met n = 93	Teneli 20mg+Met n = 91	Teneli 40mg+Met n = 88	Placebo+Met n = 88
Value	-0.58 (0.07)	-0.68 (0.07)	-0.76 (0.07)	-0.91 (0.07)	-0.28 (0.07)

Population analysed: LOCF was implemented in the Intention-to-Treat (ITT) population analysis to replace missing values for all those subjects who did not present an HbA1c value at Week 24.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teneli 5mg+Met	4 of 87 (4.6%)	43 of 87 (49.4%)	Not reported
Teneli 10 mg+Met	4 of 93 (4.3%)	43 of 93 (46.2%)	Not reported
Teneli 20 mg+Met	3 of 91 (3.3%)	41 of 91 (45.1%)	Not reported
Teneli 40 mg+Met	5 of 88 (5.7%)	36 of 88 (40.9%)	Not reported
Placebo+Met	6 of 88 (6.8%)	48 of 88 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24205974Kadowaki 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.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
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Type 2 Diabetes
Active, not recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Kerr, Dr principal investigator

Royal Bournemouth Hospital

44 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Hungary, Poland, Germany, United Kingdom, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline to Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00971243, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.