NCT01512849

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2012

Typical duration for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 11, 2014

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

January 13, 2012

Results QC Date

March 25, 2014

Last Update Submit

December 15, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

TA-7284JNJ-28431754CanagliflozinRenal ImpairmentSodium Glucose Co-transporter2 (SGLT2) inhibitor

Outcome Measures

Primary Outcomes (4)

  • Effect of Renal Function on Maximum Plasma Concentration of TA-7284

    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

    For 72 hours after each administration

  • Effect of Renal Function on Urinary Glucose Excretion of TA-7284

    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.

    For 24 hours after each administration

Secondary Outcomes (4)

  • Adverse Events

    Upto approximately 14 days after last administration

  • 12-lead Electrocardiogram (ECG)

    For 72 hours after each administration

  • Vital Signs

    For 72 hours after each administration

  • Clinical Laboratory Tests

    For 72 hours after each administration

Study Arms (2)

TA-7284 Low

EXPERIMENTAL
Drug: TA-7284 Low

TA-7284 High

EXPERIMENTAL
Drug: TA-7284 High

Interventions

TA-7284 LowDRUG

Low

TA-7284 Low
TA-7284 HighDRUG

High

TA-7284 High

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reserch site

Kanto, Japan

Location

Related Publications (1)

  • 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.

    PMID: 38770818DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Renal Insufficiency

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

  • Nobuya Inagaki, MD

    Kyoto University, Graduate School of Medicine

    STUDY DIRECTOR

  • Kazuoki Kondo, MD

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 19, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 8, 2026

Results First Posted

June 11, 2014

Record last verified: 2025-12

Locations

JP(1)