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NCT Number: NCT01512849

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Reserch site

Kanto, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TA-7284 Low

Drug

Low

TA-7284 High

Drug

High

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 19, 2012
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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