A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

Astellas Pharma Inc25 enrolled

Overview

The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

ASP1941DRUG

oral

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetic patients for at least 12 weeks * Fasting plasma glucose level of \< 240 mg/dL * Body Mass Index ( BMI )20.0 - 35.0kg/m2 * GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2 Exclusion Criteria: * Type 1 diabetes mellitus patients * Receiving insulin within 12 weeks before screening * Diabetic ketoacidosis * Dysuria and/or urinary tract infection, genital infection * Significant renal, hepatic or cardiovascular diseases * Severe gastrointestinal diseases

Locations (2)

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Outcomes

Primary Outcomes

Plasma concentration of ASP1941

Time frame: For 72 hours after dosing

Secondary Outcomes

Urinary levels of ASP1941

Time frame: For 72 hours after dosing

Urinary glucose excretion

Time frame: For 72 hours after dosing

Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs

Time frame: For 72 hours after dosing

Data from ClinicalTrials.gov

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