A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients
NCT ID: NCT01054092
Last Updated: 2025-05-30
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
PHASE3
182 participants
INTERVENTIONAL
2010-01-14
2011-07-22
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
NONE
Study Groups
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before meal group
ASP1941 will be administered before meal
ipragliflozin
oral
after meal group
ASP1941 will be administered after meal
ipragliflozin
oral
Interventions
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ipragliflozin
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c value between 6.5 and 9.5%
* Body Mass Index ( BMI )20.0 - 45.0kg/m2
Exclusion Criteria
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
* Proliferative diabetic retinopathy
20 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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Chugoku, , Japan
Chūbu, , Japan
Hokkaido, , Japan
Kansai, , Japan
Kantou, , Japan
Kyushu, , Japan
Tōhoku, , Japan
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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1941-CL-0121
Identifier Type: -
Identifier Source: org_study_id
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