Type 2 Diabetes MellitusPhase 3NCT01072331

Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus

A Phase 3 study testing MP-513 in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 1 site in Japan.

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 effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: MP-513
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 1 siteJapan
Study dates: Feb 2010to Aug 2010
Phase: Phase 3
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 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who are 20 - 75 years old
Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
Patients whose HbA1c is ≥6.5% and <10.0%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 weeks before administration of investigational drug.

Who cannot join

Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients who are accepting treatments of arrhythmias
Patients with serious diabetic complications
Patients who are the excessive alcohol addicts
Patients with severe hepatic disorder or severe renal disorder.
Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Suita, Osaka

Other trials in Japan

About this study

Official title: Pharmacokinetic/Pharmacodynamic Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.

Conditions: Type 2 Diabetes Mellitus
Being tested: MP-513, Placebo of MP-513
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-513Drug
MP-513 10 mg, once a day, for 4 weeks
MP-513Drug
MP-513 20 mg, once a day, for 4 weeks
Placebo of MP-513Drug
MP-513 placebo, once a day, for 4 weeks

Study groups in NCT01072331
Study group	Role	What they receive
MP-513 10 mg, once a day, for 4 weeks	Experimental	Not described Receives: Drug: MP-513
MP-513 20 mg, once a day, for 4 weeks	Experimental	Not described Receives: Drug: MP-513
Placebo of MP-513	Placebo comparator	Not described Receives: Drug: Placebo of MP-513

What is being measured

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

Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)
Measured: 4 weeks
Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)
Measured: 4 weeks

Secondary outcomes (2)

Change From Baseline in 24-h Mean Glucose
Measured: 4 weeks
Change From Baseline in Fasting Plasma Glucose
Measured: 4 weeks

Timeline

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

Feb 2010Aug 2010

First posted22 Feb 2010 (estimated)
Study startFeb 2010
Primary completionAug 2010
Study completionAug 2010

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01072331
Sponsor's protocol ID: 3000-A12
Status last verified: Dec 2025
First submitted: 18 Feb 2010
Last updated: 2 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Eto T, Inoue S, Kadowaki T. Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2012 Nov;14(11):1040-6. doi: 10.1111/j.1463-1326.2012.01662.x. Epub 2012 Jul 29.
PubMed 22776014

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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic/Pharmacodynamic Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01072331
Acronym / sponsor ID: 3000-A12
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 22 Feb 2010 (estimated)
Results: Posted 19 Dec 2012

Clinical summary

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

The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
MP-513 10 mg, once a day, for 4 weeks	Experimental	Drug: MP-513
MP-513 20 mg, once a day, for 4 weeks	Experimental	Drug: MP-513
Placebo of MP-513	Placebo comparator	Drug: Placebo of MP-513

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients who are 20 - 75 years old
Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
Patients whose HbA1c is ≥6.5% and <10.0%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 weeks before administration of investigational drug.

Key exclusion criteria (6 listed)

Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients who are accepting treatments of arrhythmias
Patients with serious diabetic complications
Patients who are the excessive alcohol addicts
Patients with severe hepatic disorder or severe renal disorder.

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-513MP-513 10 mg, once a day, for 4 weeks	Drug	MP-513 10 mg, once a day, for 4 weeks
MP-513MP-513 20 mg, once a day, for 4 weeks	Drug	MP-513 20 mg, once a day, for 4 weeks
Placebo of MP-513MP-513 placebo, once a day, for 4 weeks	Drug	Placebo of MP-513

Primary outcome

Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)
Time frame: 4 weeks
Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)
Time frame: 4 weeks

2 secondary outcomes

Change From Baseline in 24-h Mean Glucose
Time frame: 4 weeks
Change From Baseline in Fasting Plasma Glucose
Time frame: 4 weeks

Results and safety

Results posted to the registry on 19 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MP-513 10 mg	34	34
MP-513 20 mg	33	33
Placebo of MP-513	32	32

Primary outcome: Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)

Time frame: 4 weeks. Least squares mean (Standard Error). Unit: mg / dL

Measure	MP-513 10 mg n = 34	MP-513 20 mg n = 33	Placebo of MP-513 n = 32
2-h Postprandial Glucose (breakfast)	-56.2 (5.5)	-43.7 (5.8)	-5.5 (6.0)
2-h Postprandial Glucose (lunch)	-43.1 (6.5)	-36.9 (7.0)	-8.3 (7.0)
2-h Postprandial Glucose (dinner)	-41.8 (5.4)	-40.5 (5.7)	-4.3 (5.8)

Primary outcome: Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)

Time frame: 4 weeks. Least squares mean (Standard Error). Unit: mg・h / dL

Measure	MP-513 10 mg n = 34	MP-513 20 mg n = 33	Placebo of MP-513 n = 32
Plasma Glucose AUC (breakfast)	-82.114 (8.028)	-75.437 (8.321)	-8.950 (8.294)
Plasma Glucose AUC (lunch)	-92.947 (10.592)	-86.843 (11.328)	-6.884 (11.184)
Plasma Glucose AUC (dinner)	-75.204 (9.660)	-85.192 (10.158)	-11.271 (10.218)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MP-513 10 mg	0 of 34 (0%)	8 of 34 (23.5%)	Not reported
MP-513 20 mg	0 of 33 (0%)	6 of 33 (18.2%)	Not reported
Placebo of MP-513	0 of 32 (0%)	9 of 32 (28.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22776014Eto T, Inoue S, Kadowaki T. Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2012 Nov;14(11):1040-6. doi: 10.1111/j.1463-1326.2012.01662.x. Epub 2012 Jul 29.

Related trials for Type 2 Diabetes Mellitus

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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
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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
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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.

Kazuoki Kondo, MD study director

Tanabe Pharma Corporation

Tadashi Yoshida, MD study director

Tanabe Pharma Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MP-513 in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 1 site in Japan.

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 2 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 1 site in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 19 Dec 2012). 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 From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT01072331, 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 2 Jan 2026.