CompletedPhase 1

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

Japan25 participantsStarted 2010-02-16

Plain-language summary

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.

Who can participate

Age range20 Years – 79 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Plasma concentration of ASP1941

Timeframe: For 72 hours after dosing

Trial details

NCT IDNCT01097681

SponsorAstellas Pharma Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-06-18

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials