Type 2 Diabetes MellitusPhase 1/2NCT00707954

Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients

A Phase 1/2 study testing TA-7284 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

Who is it for?: Ages 25 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: TA-7284
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 1 siteJapan
Study dates: Jun 2008to Feb 2009
Phase: Phase 1/2
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 25 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinically stable Type 2 Diabetes Mellitus
Females without childbearing potential
Body mass index (BMI) >= 18.5 kg/m2 and <= 39.9 kg/m2
Hemoglobin A1c levels >= 6.5% and <= 10%
Fasting blood glucose levels >= 140 mg/dL and <= 270 mg/dL
Systolic blood pressure >= 95 mmHg and <= 160 mmHg, and diastolic blood pressure >= 50 mmHg and <= 100 mmHg, and pulse rate >= 50 bpm

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Patients who have not been administered anti-diabetic medication within 2 weeks Prior to dosing
Medicines if necessary for Hypertension or Dyslipidemia should be administered with stable dosage at least 3 months
Treatment with diet and exercise should be unchanged for more than 3 months

Who cannot join

Type 1 Diabetes Mellitus or Secondary Diabetic Mellitus
History of diabetic complications which need treatment
Treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent
Serum creatinine > upper limit of the normal range
Patients with significant complications

Trial locations and contacts

1 site in 1 country.

Japan1 site

P-One Clinic
Hachiōji, Tokyo-to

Other trials in Japan

About this study

Official title: A Clinical Pharmacology Study of Multiple Doses of TA-7284 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step.

Conditions: Type 2 Diabetes Mellitus
Being tested: TA-7284, Placebo of TA-7284
Keywords: Diabetes, TA-7284
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

TA-7284Drug
Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)
Placebo of TA-7284Drug
Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)

Study groups in NCT00707954
Study group	Role	What they receive
TA-7284	Experimental	Not described Receives: Drug: TA-7284
Placebo of TA-7284	Placebo comparator	Not described Receives: Drug: Placebo of TA-7284

What is being measured

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

Safety: Adverse Events, Adverse Drug Reactions
In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.
Measured: 19 days

Secondary outcomes (2)

Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr
Measured: 19 days
Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin
Measured: 18 days

Timeline

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

Jun 2008Feb 2009

First posted1 Jul 2008 (estimated)
Study startJun 2008
Primary completionFeb 2009
Study completionFeb 2009

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00707954
Sponsor's protocol ID: TA-7284-02
Status last verified: Dec 2025
First submitted: 27 Jun 2008
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Iijima H, Kifuji T, Maruyama N, Inagaki N. Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Aug;32(8):768-82. doi: 10.1007/s12325-015-0234-0. Epub 2015 Aug 18.
PubMed 26280756

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 Clinical Pharmacology Study of Multiple Doses of TA-7284 in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00707954
Acronym / sponsor ID: TA-7284-02
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes, TA-7284
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 1 Jul 2008 (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.

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
TA-7284	Experimental	Drug: TA-7284
Placebo of TA-7284	Placebo comparator	Drug: Placebo of TA-7284

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Clinically stable Type 2 Diabetes Mellitus
Females without childbearing potential
Body mass index (BMI) >= 18.5 kg/m2 and <= 39.9 kg/m2
Hemoglobin A1c levels >= 6.5% and <= 10%
Fasting blood glucose levels >= 140 mg/dL and <= 270 mg/dL

Key exclusion criteria (5 listed)

Type 1 Diabetes Mellitus or Secondary Diabetic Mellitus
History of diabetic complications which need treatment
Treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent
Serum creatinine > upper limit of the normal range
Patients with significant complications

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-7284Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)	Drug	TA-7284
Placebo of TA-7284Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)	Drug	Placebo of TA-7284

Primary outcome

Safety: Adverse Events, Adverse Drug Reactions
Time frame: 19 days
In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.

2 secondary outcomes

Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr
Time frame: 19 days
Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin
Time frame: 18 days

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 25 mg	12	12
TA-7284 100 mg	12	12
TA-7284 200 mg	14	14
TA-7284 400 mg	13	13
Placebo	10	9

Primary outcome: Safety: Adverse Events, Adverse Drug Reactions

Time frame: 19 days. Number. Unit: percentage of incidences

Measure	TA-7284 25 mg n = 12	TA-7284 100 mg n = 12	TA-7284 200 mg n = 14	TA-7284 400 mg n = 13	Placebo n = 10
Adverse events	75.0	66.7	35.7	46.2	80.0
Adverse drug reactions	50.0	16.7	7.1	7.7	30.0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 19 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TA-7284 25 mg	0 of 12 (0%)	9 of 12 (75%)	Not reported
TA-7284 100 mg	0 of 12 (0%)	8 of 12 (66.7%)	Not reported
TA-7284 200 mg	0 of 14 (0%)	5 of 14 (35.7%)	Not reported
TA-7284 400 mg	0 of 13 (0%)	6 of 13 (46.2%)	Not reported
Placebo	0 of 10 (0%)	8 of 10 (80%)	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 26280756Iijima H, Kifuji T, Maruyama N, Inagaki N. Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Aug;32(8):768-82. doi: 10.1007/s12325-015-0234-0. Epub 2015 Aug 18.

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
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Not yet recruiting
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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.

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 1/2 study testing TA-7284 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 9 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 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. 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 combined 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.

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 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: Adverse Events, Adverse Drug Reactions (time frame: 19 days). 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 NCT00707954, 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.