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CompletedNCT01512849Updated Jan 8, 2026Results posted

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 interventional study of TA-7284 Low and TA-7284 High in Type 2 Diabetes Mellitus, sponsored by Tanabe Pharma Corporation. Completed at 1 site in Japan. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Tanabe Pharma Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
40 Years to 79 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • TA-7284
  • JNJ-28431754
  • Canagliflozin
  • Renal Impairment
  • Sodium Glucose Co-transporter2 (SGLT2) inhibitor
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    TA-7284 Low

    Drug: TA-7284 Low

  • Experimental
    TA-7284 High

    Drug: TA-7284 High

Interventions

  • DrugTA-7284 Low

    Low

  • DrugTA-7284 High

    High

06

What researchers measure

Primary outcomes

  1. Effect of Renal Function on Maximum Plasma Concentration of TA-7284

    Time frame: For 72 hours after each administration

  2. 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

  3. Effect of Renal Function on Urinary Glucose Excretion of TA-7284

    Time frame: For 24 hours after each administration

  4. 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.

    Time frame: For 24 hours after each administration

Secondary outcomes

  1. Adverse Events

    Incidence and severity of AEs

    Time frame: Upto approximately 14 days after last administration

  2. 12-lead Electrocardiogram (ECG)

    Change from baseline in ECG parameters

    Time frame: For 72 hours after each administration

  3. Vital Signs

    Change from baseline in Vital signs (BP, PR and BT)

    Time frame: For 72 hours after each administration

  4. Clinical Laboratory Tests

    Change from baseline in Clinical laboratory tests

    Time frame: For 72 hours after each administration

07

Results

Posted Jun 11, 2014

Participant flow

Crossover Period 1
Participant flow — Crossover Period 1
MilestoneModerate Renal Impairment Low Dose FirstModerate Renal Impairment High Dose FirstNormal Renal Function Low Dose FirstNormal Renal Function High Dose First
Started6666
Completed6666
Not completed0000
Crossover Period 2
Participant flow — Crossover Period 2
MilestoneModerate Renal Impairment Low Dose FirstModerate Renal Impairment High Dose FirstNormal Renal Function Low Dose FirstNormal Renal Function High Dose First
Started6666
Completed6666
Not completed0000

Outcome measures

PrimaryEffect of Renal Function on Maximum Plasma Concentration of TA-7284
Time frame:
For 72 hours after each administration
Reported as:
Mean · ng / mL
Effect of Renal Function on Maximum Plasma Concentration of TA-7284
ng / mLModerate Renal Impairment LowModerate Renal Impairment HighNormal Renal Function LowNormal Renal Function High
Effect of Renal Function on Maximum Plasma Concentration of TA-72841197.1264 ± 310.56252333.3617 ± 414.89571213.6571 ± 337.87052415.6109 ± 739.8783
SecondaryAdverse Events

Incidence and severity of AEs

Time frame:
Upto approximately 14 days after last administration

Results for this outcome have not been posted.

Secondary12-lead Electrocardiogram (ECG)

Change from baseline in ECG parameters

Time frame:
For 72 hours after each administration

Results for this outcome have not been posted.

SecondaryVital Signs

Change from baseline in Vital signs (BP, PR and BT)

Time frame:
For 72 hours after each administration

Results for this outcome have not been posted.

SecondaryClinical Laboratory Tests

Change from baseline in Clinical laboratory tests

Time frame:
For 72 hours after each administration

Results for this outcome have not been posted.

PrimaryEffect 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
Reported as:
Mean · ng･h/mL
Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284
ng･h/mLModerate Renal Impairment LowModerate Renal Impairment HighNormal Renal Function LowNormal Renal Function High
Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-72848766 ± 255117835 ± 44346929 ± 173414815 ± 4162
PrimaryEffect of Renal Function on Urinary Glucose Excretion of TA-7284
Time frame:
For 24 hours after each administration
Reported as:
Mean · g
Effect of Renal Function on Urinary Glucose Excretion of TA-7284
gModerate Renal Impairment LowModerate Renal Impairment HighNormal Renal Function LowNormal Renal Function High
Effect of Renal Function on Urinary Glucose Excretion of TA-728461.017 (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)
PrimaryEffect 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.

Time frame:
For 24 hours after each administration
Reported as:
Mean · percent of RGR at baseline
Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284
percent of RGR at baselineModerate Renal Impairment LowModerate Renal Impairment HighNormal Renal Function LowNormal Renal Function High
Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-728460.8 (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)

Adverse events

Collected over Up to approximately 14 days after last administration. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Moderate Renal Impairment Low—0/12 (0%)3/12 (25%)
Moderate Renal Impairment High—0/12 (0%)1/12 (8.3%)
Normal Renal Function Low—0/12 (0%)2/12 (16.7%)
Normal Renal Function High—0/12 (0%)3/12 (25%)
Most frequent other events
Most frequent other events
EventModerate Renal Impairment LowModerate Renal Impairment HighNormal Renal Function LowNormal Renal Function High
ConstipationGastrointestinal disorders0/120/121/120/12
DiarrhoeaGastrointestinal disorders0/120/121/120/12
NasopharyngitisInfections and infestations1/121/120/121/12
Blood creatin phosphokinase increasedInvestigations0/120/120/121/12
Blood creatinine increasedInvestigations0/120/120/121/12
Blood glucose increasedInvestigations0/120/120/121/12
Protein urine presentInvestigations1/120/120/120/12
Back painMusculoskeletal and connective tissue disorders0/120/121/120/12
PollakiuriaRenal and urinary disorders1/120/120/120/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)Entire Population for Moderate Renal ImpairmentEntire Population for Normal Renal FunctionTotal
Mean63.7 ± 10.257.8 ± 9.760.8 (40 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)Entire Population for Moderate Renal ImpairmentEntire Population for Normal Renal FunctionTotal
Female000
Male121224
08

Study locations

1 site
  • Reserch site
    Kanto, Japan
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01512849
Lead sponsor
Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Jan 19, 2012
Start date
Jan 2012
Primary completion
Sep 2012
Completion
Sep 2012
Results posted
Jun 11, 2014
Last update
Jan 8, 2026

Study contacts

Nobuya Inagaki, MD
study director · Kyoto University, Graduate School of Medicine
Kazuoki Kondo, MD
study director · Tanabe Pharma Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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