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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: TA-7284 Low; Drug: TA-7284 High

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kanto, Japan
    • Reserch site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TA-7284 Low	Drug: TA-7284 Low; Low
Experimental: TA-7284 High	Drug: TA-7284 High; High

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Investigators: Study Director: Nobuya Inagaki, MD, Kyoto University, Graduate School of Medicine; Study Director: Kazuoki Kondo, MD, Tanabe Pharma Corporation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 15, 2012
• First Posted (Estimated): January 19, 2012

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Renal Impairment; Canagliflozin; JNJ-28431754; TA-7284; Sodium Glucose Co-transporter2 (SGLT2) inhibitor
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency
• Other Study ID Numbers: TA-7284-07