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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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ClinicalTrials.gov Identifier: NCT01512849
Recruitment Status : Completed
First Posted : January 19, 2012
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: TA-7284 Low Drug: TA-7284 High Phase 1

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: TA-7284 Low Drug: TA-7284 Low
Low
Experimental: TA-7284 High Drug: TA-7284 High
High



Primary Outcome Measures :
  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 [ Time Frame: For 24 hours after each administration ]
    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 :
  1. Adverse Events [ Time Frame: Upto approximately 14 days after last administration ]
    Incidence and severity of AEs

  2. 12-lead Electrocardiogram (ECG) [ Time Frame: For 72 hours after each administration ]
    Change from baseline in ECG parameters

  3. Vital Signs [ Time Frame: For 72 hours after each administration ]
    Change from baseline in Vital signs (BP, PR and BT)

  4. Clinical Laboratory Tests [ Time Frame: For 72 hours after each administration ]
    Change from baseline in Clinical laboratory tests



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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512849


Locations
Japan
Reserch site
Kanto, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Nobuya Inagaki, MD Kyoto University, Graduate School of Medicine
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01512849     History of Changes
Other Study ID Numbers: TA-7284-07
First Posted: January 19, 2012    Key Record Dates
Results First Posted: June 11, 2014
Last Update Posted: June 11, 2014
Last Verified: May 2014

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
TA-7284
JNJ-28431754
Canagliflozin
Renal Impairment
Sodium Glucose Co-transporter2 (SGLT2) inhibitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases