Type 2 Diabetes MellitusPhase 3NCT02220907

Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes

A Phase 3 study testing Teneligliptin/Canagliflozin in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 6 sites 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 co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control. 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/Canagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 6 sitesJapan
Study dates: Aug 2014to Feb 2016
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

Men or women age ≥20 years old
HbA1c of ≥7.0% and <10.5%
FPG of ≤ 270 mg/dL
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period

Who cannot join

Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
Patients with serious diabetic complications
Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
Patients with severe hepatic disorder or severe renal disorder.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Research site
Chūbu
Research site
Chugoku
Research site
Hokkaido
Research site
Kanto
Research site
Kyushu
Research site
Tōhoku

Other trials in Japan

About this study

Official title: Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Teneligliptin/Canagliflozin
Keywords: MT-2412, MP-513, TA-7284, Teneligliptin, Canagliflozin
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/CanagliflozinDrug
Also called Tenelia, MP-513, Canaglu, TA-7284
Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.

Study groups in NCT02220907
Study group	Role	What they receive
Teneligliptin/Canagliflozin	Experimental	Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks. Receives: Drug: Teneligliptin/Canagliflozin

What is being measured

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

Number of Participants With Adverse Events
Measured: 52 Weeks

Secondary outcomes (3)

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.
Measured: Baseline, 52 Weeks
Change From Baseline in Fasting Plasma Glucose Level
The change from baseline in fasting plasma glucose level collected at Week 52.
Measured: Baseline, 52 Weeks
Percentage Change in Body Weight From Baseline
The percentage change from baseline in body weight collected at Week 52.
Measured: Baseline, 52 Weeks

Timeline

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

Aug 2014Feb 2016

First posted20 Aug 2014 (estimated)
Study startAug 2014
Primary completionFeb 2016
Study completionFeb 2016

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02220907
Sponsor's protocol ID: MT-2412-J01
Status last verified: Dec 2025
First submitted: 19 Aug 2014
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31.
PubMed 28608617

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: Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02220907
Acronym / sponsor ID: MT-2412-J01
Conditions: Type 2 Diabetes Mellitus
Keywords: MT-2412, MP-513, TA-7284, Teneligliptin, Canagliflozin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 20 Aug 2014 (estimated)
Results: Posted 16 Aug 2018

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Teneligliptin/Canagliflozin	Experimental	Drug: Teneligliptin/CanagliflozinPatients receive Teneligliptin and Canagliflozin once daily for 52 weeks.

Who may qualify

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

Key inclusion criteria (4 listed)

Men or women age ≥20 years old
HbA1c of ≥7.0% and <10.5%
FPG of ≤ 270 mg/dL
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period

Key exclusion criteria (5 listed)

Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
Patients with serious diabetic complications
Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
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
Teneligliptin/CanagliflozinAlso: Tenelia, MP-513, Canaglu, TA-7284Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.	Drug	Teneligliptin/Canagliflozin

Primary outcome

Number of Participants With Adverse Events
Time frame: 52 Weeks

3 secondary outcomes

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 52 Weeks
Change From Baseline in Fasting Plasma Glucose Level
Time frame: Baseline, 52 Weeks
Percentage Change in Body Weight From Baseline
Time frame: Baseline, 52 Weeks

Results and safety

Results posted to the registry on 16 Aug 2018, 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+Canagliflozin	153	142

Primary outcome: Number of Participants With Adverse Events

Time frame: 52 Weeks. Number. Unit: participants

Measure	Teneligliptin+Canagliflozin n = 153
Serious Adverse Event	11
Adverse Event	107

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teneligliptin+Canagliflozin	11 of 153 (7.2%)	61 of 153 (39.9%)	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.
Results publication: PubMed 28608617Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
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)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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, MD study director

Tokyo University

Nobuya Inagaki, MD study director

Kyoto University

Kazuoki Kondo, MD study director

Tanabe Pharma Corporation

6 sites 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/Canagliflozin in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 6 sites 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 5 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 6 sites 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 16 Aug 2018). 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 NCT02220907, 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.