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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
TA-7284 Low
TA-7284 High
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring TA-7284, JNJ-28431754, Canagliflozin, Renal Impairment, Sodium Glucose Co-transporter2 (SGLT2) inhibitor

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Reserch site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TA-7284 Low

TA-7284 High

Arm Description

Outcomes

Primary Outcome Measures

Effect of Renal Function on Maximum Plasma Concentration of TA-7284
Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284
Effect of Renal Function on Urinary Glucose Excretion of TA-7284
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.

Secondary Outcome Measures

Adverse Events
Incidence and severity of AEs
12-lead Electrocardiogram (ECG)
Change from baseline in ECG parameters
Vital Signs
Change from baseline in Vital signs (BP, PR and BT)
Clinical Laboratory Tests
Change from baseline in Clinical laboratory tests

Full Information

First Posted
January 13, 2012
Last Updated
May 13, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01512849
Brief Title
A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
TA-7284, JNJ-28431754, Canagliflozin, Renal Impairment, Sodium Glucose Co-transporter2 (SGLT2) inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TA-7284 Low
Arm Type
Experimental
Arm Title
TA-7284 High
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TA-7284 Low
Intervention Description
Low
Intervention Type
Drug
Intervention Name(s)
TA-7284 High
Intervention Description
High
Primary Outcome Measure Information:
Title
Effect of Renal Function on Maximum Plasma Concentration of TA-7284
Time Frame
For 72 hours after each administration
Title
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
Title
Effect of Renal Function on Urinary Glucose Excretion of TA-7284
Time Frame
For 24 hours after each administration
Title
Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284
Description
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 Outcome Measure Information:
Title
Adverse Events
Description
Incidence and severity of AEs
Time Frame
Upto approximately 14 days after last administration
Title
12-lead Electrocardiogram (ECG)
Description
Change from baseline in ECG parameters
Time Frame
For 72 hours after each administration
Title
Vital Signs
Description
Change from baseline in Vital signs (BP, PR and BT)
Time Frame
For 72 hours after each administration
Title
Clinical Laboratory Tests
Description
Change from baseline in Clinical laboratory tests
Time Frame
For 72 hours after each administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuya Inagaki, MD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Reserch site
City
Kanto
Country
Japan

12. IPD Sharing Statement

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

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