A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
NCT ID: NCT00790660
Last Updated: 2024-11-14
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
PHASE2
61 participants
INTERVENTIONAL
2008-10-23
2009-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ASP1941 Lowest Dose
Oral
ASP1941
Oral
ASP1941 Low Dose
Oral
ASP1941
Oral
ASP1941 Medium Dose
Oral
ASP1941
Oral
ASP1941 High Dose
Oral
ASP1941
Oral
Placebo
Oral
Placebo
Oral
Interventions
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ASP1941
Oral
Placebo
Oral
Eligibility Criteria
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Inclusion Criteria
* HbA1c value between 7.0 and 10.0%
* Body mass index between 20 and 45 kg/m2
Exclusion Criteria
* Serum creatinine \> upper limit of normal range
* Proteinuria (microalbumin/creatinine ratio \> 300 mg/g)
* Urinary tract infection
* Severe uncontrolled Hypertension
* Significant renal, hepatic or cardiovascular disease
* HIV Positive
* History of drug or alcohol abuse/dependency
18 Years
75 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_DIRECTOR
Astellas Pharma Global Development
Locations
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San Antonio, Texas, United States
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website.
Other Identifiers
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1941-CL-0016
Identifier Type: -
Identifier Source: org_study_id
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