Type 2 Diabetes MellitusPhase 3NCT01387737

Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing TA-7284-Low and TA-7284-High in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 7 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 TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral 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?: TA-7284-Low and TA-7284-High
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,299 participants
Where: 7 sitesJapan
Study dates: May 2011to Dec 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

Men or women age ≥20 years old
Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

Who cannot join

Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
Past or current history of severe diabetic complications
Fasting plasma glucose > 270 mg/dL before treatment start
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Patients requiring insulin therapy

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

Research site
Chugoku
Research site
Hokkaido
Research site
Kanto
Research site
Kinki
Research site
Kyushu
Research site
Shikoku
Research site
Tōhoku

Other trials in Japan

About this study

Official title: An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus

Read the detailed description

This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Conditions: Type 2 Diabetes Mellitus
Being tested: TA-7284-Low, TA-7284-High
Keywords: TA-7284, JNJ-28431754, Canagliflozin, Sodium Glucose Co-Transporter (SGLT2 inhibitor)
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.

TA-7284-LowDrug
TA-7284-Low
TA-7284-HighDrug
TA-7284-High

Study groups in NCT01387737
Study group	Role	What they receive
TA-7284-Low	Experimental	Not described Receives: Drug: TA-7284-Low
TA-7284-High	Experimental	Not described Receives: Drug: TA-7284-High

What is being measured

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

Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
Measured: 54 weeks

Secondary outcomes (4)

Change in HbA1c
Measured: Week 52
Change in Fasting Plasma Glucose
Measured: Week 52
Change in Body Weight
Measured: Week 52
Change in Blood Pressure
Measured: Week 52

Timeline

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

May 2011Dec 2012

First posted6 Jul 2011 (estimated)
Study startMay 2011
Primary completionNov 2012
Study completionDec 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 (2)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: None (open label)
Enrolment: 1,299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01387737
Sponsor's protocol ID: TA-7284-06
Status last verified: Dec 2025
First submitted: 28 Jun 2011
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Inagaki N, Goda M, Yokota S, Maruyama N, Iijima H. Effects of Baseline Blood Pressure and Low-Density Lipoprotein Cholesterol on Safety and Efficacy of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Nov;32(11):1085-103. doi: 10.1007/s12325-015-0255-8. Epub 2015 Nov 3.
PubMed 26530268
Inagaki N, Kondo K, Yoshinari T, Kuki H. Efficacy and safety of canagliflozin alone or as add-on to other oral antihyperglycemic drugs in Japanese patients with type 2 diabetes: A 52-week open-label study. J Diabetes Investig. 2015 Mar;6(2):210-8. doi: 10.1111/jdi.12266. Epub 2014 Aug 25.
PubMed 25802729

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

Official title: An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01387737
Acronym / sponsor ID: TA-7284-06
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284, JNJ-28431754, Canagliflozin, Sodium Glucose Co-Transporter (SGLT2 inhibitor)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,299 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Nov 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 6 Jul 2011 (estimated)
Results: Posted 28 Apr 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TA-7284-Low	Experimental	Drug: TA-7284-Low
TA-7284-High	Experimental	Drug: TA-7284-High

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
Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

Key exclusion criteria (5 listed)

Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
Past or current history of severe diabetic complications
Fasting plasma glucose > 270 mg/dL before treatment start
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Patients requiring insulin therapy

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
TA-7284-LowTA-7284-Low	Drug	TA-7284-Low
TA-7284-HighTA-7284-High	Drug	TA-7284-High

Primary outcome

Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
Time frame: 54 weeks

4 secondary outcomes

Change in HbA1c
Time frame: Week 52
Change in Fasting Plasma Glucose
Time frame: Week 52
Change in Body Weight
Time frame: Week 52
Change in Blood Pressure
Time frame: Week 52

Results and safety

Results posted to the registry on 28 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TA-7284-Low	584	532
TA-7284-High	715	641

Primary outcome: Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events

Time frame: 54 weeks. Number. Unit: percentage of incidences

Measure	TA-7284-Low n = 584	TA-7284-High n = 715
adverse events	81.8	82.8
hypoglycemia	14.9	13.3

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 52. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TA-7284-Low	30 of 584 (5.1%)	371 of 584 (63.5%)	Not reported
TA-7284-High	32 of 715 (4.5%)	464 of 715 (64.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26530268Inagaki N, Goda M, Yokota S, Maruyama N, Iijima H. Effects of Baseline Blood Pressure and Low-Density Lipoprotein Cholesterol on Safety and Efficacy of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Nov;32(11):1085-103. doi: 10.1007/s12325-015-0255-8. Epub 2015 Nov 3.
Derived from this study: PubMed 25802729Inagaki N, Kondo K, Yoshinari T, Kuki H. Efficacy and safety of canagliflozin alone or as add-on to other oral antihyperglycemic drugs in Japanese patients with type 2 diabetes: A 52-week open-label study. J Diabetes Investig. 2015 Mar;6(2):210-8. doi: 10.1111/jdi.12266. Epub 2014 Aug 25.

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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
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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.

Nobuya Inagaki, M.D. study director

Kyoto University, Graduate School of Medicine

Kazuoki Kondo, M.D. study director

Tanabe Pharma Corporation

7 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 TA-7284-Low and TA-7284-High in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 7 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 8 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 7 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 28 Apr 2014). 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?

Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events (time frame: 54 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 NCT01387737, which also lists 2 linked publications.

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 8 Jan 2026.