Type 2 Diabetes MellitusPhase 3NCT02354235

Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)

A Phase 3 study testing Teneligliptin and Canagliflozin in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 3 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 efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 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 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Teneligliptin and Canagliflozin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 138 participants
Where: 3 sitesJapan
Study dates: Jan 2015to Jan 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women who are 20 - 75 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 8 weeks before run-in 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

3 sites in 1 country.

Japan3 sites

Reserch site
Kanto
Reserch site
Kinki
Reserch site
Tōhoku

Other trials in Japan

About this study

Official title: Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin in Patients With Inadequate Glycemic Control on Teneligliptin)

Conditions: Type 2 Diabetes Mellitus
Being tested: Teneligliptin, Canagliflozin, Placebo
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.

TeneligliptinDrug
Also called Tenelia, MP-513
CanagliflozinDrug
Also called Canaglu, TA-7284
PlaceboDrug

Study groups in NCT02354235
Study group	Role	What they receive
Canagliflozin + Teneligliptin	Experimental	Patients receive Canagliflozin for 24 weeks in combination with Teneligliptin. Receives: Drug: Teneligliptin; Drug: Canagliflozin
Placebo + Teneligliptin	Placebo comparator	Patients receive placebo for 24 weeks in combination with Teneligliptin. Receives: Drug: Teneligliptin; Drug: Placebo

What is being measured

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

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 24.
Measured: Baseline, 24 Weeks

Secondary outcomes (4)

Change From Baseline in Fasting Plasma Glucose Level
The change from baseline in fasting plasma glucose level collected at Week 24.
Measured: Baseline, 24 Weeks
Percentage Change in Body Weight From Baseline
The percentage change from baseline in body weight collected at Week 24.
Measured: Baseline, 24 Weeks
Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.
Measured: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks
Change From Baseline in 2-hour Postprandial Plasma Glucose Level
The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.
Measured: 2 Hours Postprandial, at Baseline and 24 Weeks

Timeline

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

Jan 2015Jan 2016

First posted3 Feb 2015 (estimated)
Study startJan 2015
Primary completionJan 2016
Study completionJan 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02354235
Sponsor's protocol ID: MT-2412-J03
Status last verified: Dec 2025
First submitted: 29 Jan 2015
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, Iijima H, Watanabe Y, Gouda M. Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Jun;19(6):874-882. doi: 10.1111/dom.12898. Epub 2017 Mar 31.
PubMed 28177187

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: Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin in Patients With Inadequate Glycemic Control on Teneligliptin)
ClinicalTrials.gov ID: NCT02354235
Acronym / sponsor ID: MT-2412-J03
Conditions: Type 2 Diabetes Mellitus
Keywords: MT-2412, MP-513, TA-7284, Teneligliptin, Canagliflozin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Jan 2016 (actual)
Study completion: Jan 2016 (actual)
First posted: 3 Feb 2015 (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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Canagliflozin + Teneligliptin	Experimental	Drug: Teneligliptin, Drug: CanagliflozinPatients receive Canagliflozin for 24 weeks in combination with Teneligliptin.
Placebo + Teneligliptin	Placebo comparator	Drug: Teneligliptin, Drug: PlaceboPatients receive placebo for 24 weeks in combination with Teneligliptin.

Who may qualify

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

Key inclusion criteria (4 listed)

Men or women who are 20 - 75 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 8 weeks before run-in 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
TeneligliptinAlso: Tenelia, MP-513	Drug	Canagliflozin + Teneligliptin, Placebo + Teneligliptin
CanagliflozinAlso: Canaglu, TA-7284	Drug	Canagliflozin + Teneligliptin
Placebo	Drug	Placebo + Teneligliptin

Primary outcome

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 24 Weeks
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 24.

4 secondary outcomes

Change From Baseline in Fasting Plasma Glucose Level
Time frame: Baseline, 24 Weeks
Percentage Change in Body Weight From Baseline
Time frame: Baseline, 24 Weeks
Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
Time frame: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks
Change From Baseline in 2-hour Postprandial Plasma Glucose Level
Time frame: 2 Hours Postprandial, at Baseline and 24 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
Canagliflozin+Teneligliptin	70	67
Placebo+Teneligliptin	68	61

Primary outcome: Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)

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

Measure	Canagliflozin+Teneligliptin n = 70	Placebo+Teneligliptin n = 68
Value	-0.97 (0.10)	-0.10 (0.10)

Canagliflozin+Teneligliptin vs Placebo+Teneligliptin: Least Squares Mean Difference: -0.88 (95% CI -1.15 to -0.60), p <0.001, ANCOVA

Population analysed: Full analysis set, last observation carried forward

4 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
Canagliflozin+Teneligliptin	1 of 70 (1.4%)	13 of 70 (18.6%)	Not reported
Placebo+Teneligliptin	2 of 68 (2.9%)	11 of 68 (16.2%)	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 28177187Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Iijima H, Watanabe Y, Gouda M. Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Jun;19(6):874-882. doi: 10.1111/dom.12898. Epub 2017 Mar 31.

Related trials for Type 2 Diabetes Mellitus

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, MD study director

Tokyo University

Kazuoki Kondo, MD study director

Tanabe Pharma Corporation

3 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 and Canagliflozin in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 3 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 3 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. 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 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?

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) (time frame: Baseline, 24 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 NCT02354235, 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.