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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: May 13, 2014
Last verified: May 2014
  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 Maximum Plasma Concentration of TA-7284 [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Effect of Renal Function on Urinary Glucose Excretion of TA-7284 [ Time Frame: For 24 hours after each administration ] [ Designated as safety issue: No ]
  • Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284 [ Time Frame: For 24 hours after each administration ] [ Designated as safety issue: No ]
    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 [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 25, 2014
Last Updated: May 13, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014