Trial record 1 of 1 for:    TA-7284-07
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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01512849
First received: January 13, 2012
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: TA-7284 Low
Drug: TA-7284 High
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Effect of renal function on the pharmacokinetics/dynamics of TA-7284 [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]
    To characterize the PK and PD profile in patients with type 2 diabetes mellitus who have moderate renal impairment, compared with patients with type 2 diabetes mellitus who have normal renal function.


Secondary Outcome Measures:
  • Adverse events [ Time Frame: Upto approximately 14 days after last administration ] [ Designated as safety issue: Yes ]
    Incidence and severity of AEs

  • 12-lead electrocardiogram (ECG) [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]
    Change from baseline in ECG parameters

  • Vital signs [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]
    Change from baseline in Vital signs (BP, PR and BT)

  • Clinical laboratory tests [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]
    Change from baseline in Clinical laboratory tests


Enrollment: 24
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TA-7284 Low Drug: TA-7284 Low
Low
Experimental: TA-7284 High Drug: TA-7284 High
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.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01512849     History of Changes
Other Study ID Numbers: TA-7284-07
Study First Received: January 13, 2012
Last Updated: September 19, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 20, 2014