Type 2 Diabetes MellitusPhase 2NCT01022112

An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes

A Phase 2 study testing TA-7284-Low, TA-7284-Low-middle and TA-7284-High-middle 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 demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: TA-7284-Low, TA-7284-Low-middle and TA-7284-High-middle
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 383 participants
Where: 6 sitesJapan
Study dates: Nov 2009to Sep 2010
Phase: Phase 2
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged from 20 to 80 years inclusive on the day of informed consent;
Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;
Patients with HbA1c of ≥6.5% and ≤9.5% (according to the Japan Diabetic Society [JDS] criteria) on the start day of the run-in period;

Who cannot join

Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
Fasting blood glucose of >270 mg/dL on the start day of the run-in period or at Week 2 of the run-in period;
eGFR of <60 mL/min/1.73 m2 on the start day of the run-in period;
Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
History of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;

Show all 11Show fewer

Concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;
Past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor.
Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
Pregnant women, lactating mothers, or women of childbearing potential;
Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

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

Other trials in Japan

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally-Administered SGLT2 Inhibitor TA-7284

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

Read the detailed description

Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of T2DM and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, placebo-controlled, parallel-group study to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with T2DM, who are not optimally controlled on diet and exercise. The primary study hypothesis is that the study drug will be superior to placebo as assessed by the change in HbA1c from baseline. The patients will receive tablets of TA-7284, or placebo, once daily for 12 weeks.

Conditions: Type 2 Diabetes Mellitus
Being tested: TA-7284-Low, TA-7284-Low-middle, TA-7284-High-middle, TA-7284-High, Placebo
Keywords: TA-7284, JNJ-28431754, Canagliflozin, Type 2 diabetes mellitus, 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-Low-middleDrug
TA-7284-Low-middle
TA-7284-High-middleDrug
TA-7284-High-middle
TA-7284-HighDrug
TA-7284-High
PlaceboDrug
Placebo

Study groups in NCT01022112
Study group	Role	What they receive
TA-7284-Low	Experimental	Not described Receives: Drug: TA-7284-Low
TA-7284-Low-middle	Experimental	Not described Receives: Drug: TA-7284-Low-middle
TA-7284-High-middle	Experimental	Not described Receives: Drug: TA-7284-High-middle
TA-7284-High	Experimental	Not described Receives: Drug: TA-7284-High
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
Measured: 12 weeks

Secondary outcomes (2)

Fasting Blood Glucose, Body Weight
Measured: 12 weeks
Safety and Tolerability
Measured: 14 weeks

Timeline

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

Nov 2009Sep 2010

First posted1 Dec 2009 (estimated)
Study startNov 2009
Primary completionSep 2010
Study completionSep 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01022112
Sponsor's protocol ID: TA-7284-04
Status last verified: Dec 2025
First submitted: 29 Nov 2009
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally-Administered SGLT2 Inhibitor TA-7284
ClinicalTrials.gov ID: NCT01022112
Acronym / sponsor ID: TA-7284-04
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284, JNJ-28431754, Canagliflozin, Type 2 diabetes mellitus, Sodium Glucose Co-transporter (SGLT2 inhibitor)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 1 Dec 2009 (estimated)
Results: Posted 5 Jun 2014

Clinical summary

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

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
TA-7284-Low	Experimental	Drug: TA-7284-Low
TA-7284-Low-middle	Experimental	Drug: TA-7284-Low-middle
TA-7284-High-middle	Experimental	Drug: TA-7284-High-middle
TA-7284-High	Experimental	Drug: TA-7284-High
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged from 20 to 80 years inclusive on the day of informed consent;
Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;
Patients with HbA1c of ≥6.5% and ≤9.5% (according to the Japan Diabetic Society [JDS] criteria) on the start day of the run-in period;

Key exclusion criteria (11 listed)

Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
Fasting blood glucose of >270 mg/dL on the start day of the run-in period or at Week 2 of the run-in period;
eGFR of <60 mL/min/1.73 m2 on the start day of the run-in period;
Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;

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-Low-middleTA-7284-Low-middle	Drug	TA-7284-Low-middle
TA-7284-High-middleTA-7284-High-middle	Drug	TA-7284-High-middle
TA-7284-HighTA-7284-High	Drug	TA-7284-High
PlaceboPlacebo	Drug	Placebo

Primary outcome

Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
Time frame: 12 weeks

2 secondary outcomes

Fasting Blood Glucose, Body Weight
Time frame: 12 weeks
Safety and Tolerability
Time frame: 14 weeks

Results and safety

Results posted to the registry on 5 Jun 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	82	79
TA-7284-Low-middle	74	71
TA-7284-High-middle	77	74
TA-7284-High	75	72
Placebo	75	65

Primary outcome: Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)

Time frame: 12 weeks. Least squares mean (Standard Error). Unit: percent HbA1C

Measure	TA-7284-Low n = 82	TA-7284-Low-middle n = 74	TA-7284-High-middle n = 75	TA-7284-High n = 75	Placebo n = 75
Value	-0.61 (0.06)	-0.80 (0.06)	-0.79 (0.06)	-0.88 (0.06)	0.11 (0.06)

Population analysed: Full analysis set, last observation carried forward

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TA-7284-Low	1 of 82 (1.2%)	36 of 82 (43.9%)	Not reported
TA-7284-Low-middle	0 of 74 (0%)	34 of 74 (45.9%)	Not reported
TA-7284-High-middle	0 of 77 (0%)	38 of 77 (49.4%)	Not reported
TA-7284-High	0 of 75 (0%)	34 of 75 (45.3%)	Not reported
Placebo	0 of 75 (0%)	26 of 75 (34.7%)	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.

Related trials for Type 2 Diabetes Mellitus

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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

Tadashi Yoshida, M.D. 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 2 study testing TA-7284-Low, TA-7284-Low-middle and TA-7284-High-middle 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 3 inclusion and 11 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Jun 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?

Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) (time frame: 12 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 NCT01022112.

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.