A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
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An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function
Actual Study Start Date :
February 16, 2010
Actual Primary Completion Date :
June 18, 2010
Actual Study Completion Date :
June 18, 2010
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Layout table for eligibility information
Ages Eligible for Study:
20 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Type 1 diabetes mellitus patients
Receiving insulin within 12 weeks before screening
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."