Type 2 Diabetes MellitusPhase 3NCT01301833

Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

A Phase 3 study testing teneligliptin, glinide and biguanide 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 safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: teneligliptin, glinide and biguanide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 462 participants
Where: 1 siteJapan
Study dates: Feb 2011to Sep 2012
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is between 6.5% - 10.0%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 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 habitual excessive alcohol consumption.
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
Chitose-shi, Hokkaido

Other trials in Japan

About this study

Official title: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: teneligliptin, glinide, biguanide, alpha-glucosidase inhibitor
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.

teneligliptinDrug
Also called MP-513
glinideDrug
biguanideDrug
alpha-glucosidase inhibitorDrug

Study groups in NCT01301833
Study group	Role	What they receive
teneligliptin	Experimental	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) Receives: Drug: teneligliptin
teneligliptin and glinide	Experimental	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide Receives: Drug: teneligliptin; Drug: glinide
teneligliptin and biguanide	Experimental	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide Receives: Drug: teneligliptin; Drug: biguanide
teneligliptin and alpha-glucosidase inhibitor	Experimental	teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor Receives: Drug: teneligliptin; Drug: alpha-glucosidase inhibitor

What is being measured

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

Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Measured: 52 Weeks

Secondary outcomes (4)

Change From Baseline in HbA1c at Week 52
Measured: Baseline and 52 weeks
Change From Baseline in Fasting Plasma Glucose at Week 52
Measured: Baseline and 52 weeks
Change From Baseline in Fasting Glucagon at Week 52
Measured: Baseline and 52 weeks
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
Measured: Baseline and 52 weeks

Timeline

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

Feb 2011Sep 2012

First posted23 Feb 2011 (estimated)
Study startFeb 2011
Primary completionSep 2012
Study completionSep 2012

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 462 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301833
Sponsor's protocol ID: 3000-A14
Status last verified: Dec 2025
First submitted: 14 Feb 2011
Last updated: 2 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.
PubMed 25861982

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: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01301833
Acronym / sponsor ID: 3000-A14
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 462 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 23 Feb 2011 (estimated)
Results: Posted 28 Aug 2015

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
teneligliptin	Experimental	Drug: teneligliptinteneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
teneligliptin and glinide	Experimental	Drug: teneligliptin, Drug: glinideteneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
teneligliptin and biguanide	Experimental	Drug: teneligliptin, Drug: biguanideteneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
teneligliptin and alpha-glucosidase inhibitor	Experimental	Drug: teneligliptin, Drug: alpha-glucosidase inhibitorteneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor

Who may qualify

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

Key inclusion criteria (4 listed)

Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is between 6.5% - 10.0%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 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 habitual excessive alcohol consumption.
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
teneligliptinAlso: MP-513	Drug	teneligliptin, teneligliptin and alpha-glucosidase inhibitor, teneligliptin and biguanide, teneligliptin and glinide
glinide	Drug	teneligliptin and glinide
biguanide	Drug	teneligliptin and biguanide
alpha-glucosidase inhibitor	Drug	teneligliptin and alpha-glucosidase inhibitor

Primary outcome

Number of Participants With Adverse Events
Time frame: 52 Weeks
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.

4 secondary outcomes

Change From Baseline in HbA1c at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Plasma Glucose at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Glucagon at Week 52
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
Time frame: Baseline and 52 weeks

Results and safety

Results posted to the registry on 28 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teneligliptin	212	197
Teneligliptin and Glinide	80	72
Teneligliptin and Biguanide	95	88
Teneligliptin and Alpha-glucosidase Inhibitor	75	68

Primary outcome: Number of Participants With Adverse Events

Time frame: 52 Weeks. Number. Unit: participants

Measure	Teneligliptin n = 212	Teneligliptin and Glinide n = 80	Teneligliptin and Biguanide n = 95	Teneligliptin and Alpha-glucosidase Inhibitor n = 75
Serious Adverse Event	14	3	6	6
Other Adverse Event	182	72	81	59

Population analysed: Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teneligliptin	14 of 212 (6.6%)	182 of 212 (85.8%)	Not reported
Teneligliptin and Glinide	3 of 80 (3.8%)	72 of 80 (90%)	Not reported
Teneligliptin and Biguanide	6 of 95 (6.3%)	81 of 95 (85.3%)	Not reported
Teneligliptin and Alpha-glucosidase Inhibitor	6 of 75 (8%)	59 of 75 (78.7%)	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 25861982Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
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Active, not recruiting
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Recruiting
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Not yet recruitingPhase 3
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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.

Takashi Kadowaki, Professor study director

Tokyo University

Kazuoki Kondo, 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 teneligliptin, glinide and biguanide 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. 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 28 Aug 2015). 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?

Number of Participants With Adverse Events (time frame: 52 Weeks). 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 NCT01301833, 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.