Type 2 Diabetes MellitusPhase 3NCT02924064

Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Teneligliptin 20mg and Metformin ≥ 1000 mg in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 1 site in China.

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

This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with metformin. 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?: Teneligliptin 20mg and Metformin ≥ 1000 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 247 participants
Where: 1 siteChina
Study dates: Sep 2016to 25 Sep 2018
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A signed and dated informed consent form obtained from the subject, in accordance.
The subject is aged ≥18 years at signature of the informed consent form.
Hospitalization status: outpatient.
The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
The subject's HbA1c is ≥ 7.0% and < 10.0% at the screening visit (Day -28) and on Day -14.

Who cannot join

The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (< 2 weeks' duration).
The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).

Trial locations and contacts

1 site in 1 country.

China1 site

Investigational center
Beijing

Other trials in China

About this study

Conditions: Type 2 Diabetes Mellitus
Being tested: Teneligliptin 20mg, Placebo, Metformin ≥ 1000 mg
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

Teneligliptin 20mgDrug
PlaceboDrug
Metformin ≥ 1000 mgDrug

Study groups in NCT02924064
Study group	Role	What they receive
Teneligliptin 20mg	Experimental	Teneligliptin (20mg once daily) for 24 weeks in combination with metformin Receives: Drug: Teneligliptin 20mg; Drug: Metformin ≥ 1000 mg
Placebo	Placebo comparator	Placebo for 24 weeks in combination with metformin Receives: Drug: Placebo; Drug: Metformin ≥ 1000 mg

What is being measured

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

The Changes in HbA1c at Week 24
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Measured: at Day 1(baseline) and Week 24

Secondary outcomes (1)

The Changes in Fasting Plasma Glucose (FPG) at Week 24
The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Measured: at Day 1(baseline) and Week 24

Timeline

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

Sep 201625 Sep 2018

First posted5 Oct 2016 (estimated)
Study startSep 2016
Primary completion25 Sep 2018

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.
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
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02924064
Sponsor's protocol ID: MP-513-C03
Status last verified: Dec 2025
First submitted: 26 Sep 2016
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov

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

Official title: Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02924064
Acronym / sponsor ID: MP-513-C03
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Sep 2016
Primary completion: 25 Sep 2018 (actual)
First posted: 5 Oct 2016 (estimated)
Results: Posted 28 Jan 2022

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
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Teneligliptin 20mg	Experimental	Drug: Teneligliptin 20mg, Drug: Metformin ≥ 1000 mgTeneligliptin (20mg once daily) for 24 weeks in combination with metformin
Placebo	Placebo comparator	Drug: Placebo, Drug: Metformin ≥ 1000 mgPlacebo for 24 weeks in combination with metformin

Who may qualify

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

Key inclusion criteria (6 listed)

A signed and dated informed consent form obtained from the subject, in accordance.
The subject is aged ≥18 years at signature of the informed consent form.
Hospitalization status: outpatient.
The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.

Key exclusion criteria (3 listed)

The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (< 2 weeks' duration).
The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).

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
Teneligliptin 20mg	Drug	Teneligliptin 20mg
Placebo	Drug	Placebo
Metformin ≥ 1000 mg	Drug	Placebo, Teneligliptin 20mg

Primary outcome

The Changes in HbA1c at Week 24
Time frame: at Day 1(baseline) and Week 24
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.

1 secondary outcome

The Changes in Fasting Plasma Glucose (FPG) at Week 24
Time frame: at Day 1(baseline) and Week 24

Results and safety

Results posted to the registry on 28 Jan 2022, 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 20mg + Metformin	123	99
Placebo + Metformin	124	81

Primary outcome: The Changes in HbA1c at Week 24

Time frame: at Day 1(baseline) and Week 24. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	Teneligliptin 20mg + Metformin n = 122	Placebo + Metformin n = 124
Value	-0.72 (0.07)	-0.01 (0.07)

Population analysed: All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period and have at least one post-baseline efficacy observation. Subjects who were not diagnosed with type 2 diabetes mellitus were excluded.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teneligliptin 20mg + Metformin	4 of 124 (3.2%)	35 of 124 (28.2%)	0 of 124
Placebo + Metformin	6 of 123 (4.9%)	43 of 123 (35%)	0 of 123

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

General Manager 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 20mg and Metformin ≥ 1000 mg in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 1 site in China.

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 6 inclusion and 3 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 6 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 China. 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 28 Jan 2022). 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?

The Changes in HbA1c at Week 24 (time frame: at Day 1(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 NCT02924064.

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 6 Jan 2026.