A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
NCT ID: NCT01097681
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2010-02-16
2010-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Normal renal function group
oral
ASP1941
oral
Mild renal impairment group
oral
ASP1941
oral
Moderate renal impairment group
oral
ASP1941
oral
Interventions
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ASP1941
oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
79 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Kansai, , Japan
Kantou, , Japan
Countries
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Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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1941-CL-0073
Identifier Type: -
Identifier Source: org_study_id
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