Type 2 Diabetes MellitusPhase 1NCT01512849

A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

A Phase 1 study testing TA-7284 Low and TA-7284 High in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 1 site 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 PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment. Read more about this study

Who is it for?: Ages 40 to 79 years
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: 24 participants
Where: 1 siteJapan
Study dates: Jan 2012to Sep 2012
Phase: Phase 1
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 40 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
HbA1c of ≥6.5% and ≤10.5% at screening

Who cannot join

Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
Past or current history of severe diabetic complications
Patients requiring insulin therapy
History of hereditary glucose-galactose malabsorption or primary renal glucosuria

Trial locations and contacts

1 site in 1 country.

Japan1 site

Reserch site
Kanto

Other trials in Japan

About this study

Official title: An Open-Label, Randomized, 2 Way Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

Read the detailed description

This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.

Conditions: Type 2 Diabetes Mellitus
Being tested: TA-7284 Low, TA-7284 High
Keywords: TA-7284, JNJ-28431754, Canagliflozin, Renal Impairment, Sodium Glucose Co-transporter2 (SGLT2) inhibitor
Medical subject headings: Diabetes Mellitus, Type 2, Renal Insufficiency

What participants receive

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

TA-7284 LowDrug
Low
TA-7284 HighDrug
High

Study groups in NCT01512849
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.

Effect of Renal Function on Maximum Plasma Concentration of TA-7284
Measured: For 72 hours after each administration
Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284
Measured: For 72 hours after each administration
Effect of Renal Function on Urinary Glucose Excretion of TA-7284
Measured: For 24 hours after each administration
Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284
The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.
Measured: For 24 hours after each administration

Secondary outcomes (4)

Adverse Events
Incidence and severity of AEs
Measured: Upto approximately 14 days after last administration
12-lead Electrocardiogram (ECG)
Change from baseline in ECG parameters
Measured: For 72 hours after each administration
Vital Signs
Change from baseline in Vital signs (BP, PR and BT)
Measured: For 72 hours after each administration
Clinical Laboratory Tests
Change from baseline in Clinical laboratory tests
Measured: For 72 hours after each administration

Timeline

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

Jan 2012Sep 2012

First posted19 Jan 2012 (estimated)
Study startJan 2012
Primary completionSep 2012
Study completionSep 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 (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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01512849
Sponsor's protocol ID: TA-7284-07
Status last verified: Dec 2025
First submitted: 13 Jan 2012
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818

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, Randomized, 2 Way Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
ClinicalTrials.gov ID: NCT01512849
Acronym / sponsor ID: TA-7284-07
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284, JNJ-28431754, Canagliflozin, Renal Impairment, Sodium Glucose Co-transporter2 (SGLT2) inhibitor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 19 Jan 2012 (estimated)
Results: Posted 11 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 evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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: 40 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
HbA1c of ≥6.5% and ≤10.5% at screening

Key exclusion criteria (4 listed)

Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
Past or current history of severe diabetic complications
Patients requiring insulin therapy
History of hereditary glucose-galactose malabsorption or primary renal glucosuria

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 LowLow	Drug	TA-7284 Low
TA-7284 HighHigh	Drug	TA-7284 High

Primary outcome

Effect of Renal Function on Maximum Plasma Concentration of TA-7284
Time frame: For 72 hours after each administration
Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284
Time frame: For 72 hours after each administration
Effect of Renal Function on Urinary Glucose Excretion of TA-7284
Time frame: For 24 hours after each administration
Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284
Time frame: For 24 hours after each administration
The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.

4 secondary outcomes

Adverse Events
Time frame: Upto approximately 14 days after last administration
12-lead Electrocardiogram (ECG)
Time frame: For 72 hours after each administration
Vital Signs
Time frame: For 72 hours after each administration
Clinical Laboratory Tests
Time frame: For 72 hours after each administration

Results and safety

Results posted to the registry on 11 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
Moderate Renal Impairment Low Dose First	6	6
Moderate Renal Impairment High Dose First	6	6
Normal Renal Function Low Dose First	6	6
Normal Renal Function High Dose First	6	6

Primary outcome: Effect of Renal Function on Maximum Plasma Concentration of TA-7284

Time frame: For 72 hours after each administration. Mean (Standard Deviation). Unit: ng / mL

Measure	Moderate Renal Impairment Low n = 12	Moderate Renal Impairment High n = 12	Normal Renal Function Low n = 12	Normal Renal Function High n = 12
Value	1197.1264 (310.5625)	2333.3617 (414.8957)	1213.6571 (337.8705)	2415.6109 (739.8783)

Primary outcome: Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284

Time frame: For 72 hours after each administration. Mean (Standard Deviation). Unit: ng･h/mL

Measure	Moderate Renal Impairment Low n = 12	Moderate Renal Impairment High n = 12	Normal Renal Function Low n = 12	Normal Renal Function High n = 12
Value	8766 (2551)	17835 (4434)	6929 (1734)	14815 (4162)

Primary outcome: Effect of Renal Function on Urinary Glucose Excretion of TA-7284

Time frame: For 24 hours after each administration. Mean (95% Confidence Interval). Unit: g

Measure	Moderate Renal Impairment Low n = 12	Moderate Renal Impairment High n = 12	Normal Renal Function Low n = 12	Normal Renal Function High n = 12
Value	61.017 (49.362 to 72.671)	70.904 (59.184 to 82.624)	86.592 (75.612 to 97.572)	103.052 (88.952 to 117.152)

Primary outcome: Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284

Time frame: For 24 hours after each administration. Mean (95% Confidence Interval). Unit: percent of RGR at baseline

Measure	Moderate Renal Impairment Low n = 12	Moderate Renal Impairment High n = 12	Normal Renal Function Low n = 12	Normal Renal Function High n = 12
Value	60.8 (52.4 to 69.2)	66.5 (59.5 to 73.5)	47.8 (42.2 to 53.4)	52.7 (45.4 to 60.0)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 14 days after last administration. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate Renal Impairment Low	0 of 12 (0%)	3 of 12 (25%)	Not reported
Moderate Renal Impairment High	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Normal Renal Function Low	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Normal Renal Function High	0 of 12 (0%)	3 of 12 (25%)	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 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

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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, MD study director

Kyoto University, Graduate School of Medicine

Kazuoki Kondo, MD 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 1 study testing TA-7284 Low and TA-7284 High in people with Type 2 Diabetes Mellitus, run by Tanabe Pharma Corporation at 1 site 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 4 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 11 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?

Effect of Renal Function on Maximum Plasma Concentration of TA-7284 (time frame: For 72 hours after each administration). The study lists 4 primary outcomes in all. 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 NCT01512849, 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 8 Jan 2026.