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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: TA-7284 Low
* Drug: TA-7284 High


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA-7284 Low<br> | Drug: TA-7284 Low<br>* Low<br>|
| Experimental: TA-7284 High<br> | Drug: TA-7284 High<br>* High<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TA-7284, JNJ-28431754, Canagliflozin, Renal Impairment, Sodium Glucose Co-transporter2 (SGLT2) inhibitor