A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01023945
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
30 participants
INTERVENTIONAL
2009-11-07
2010-03-26
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
QUADRUPLE
Study Groups
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ASP1941 high dose group
oral
ASP1941
oral
ASP1941 low dose group
oral
ASP1941
oral
Placebo group
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% at screening
* Fasting plasma glucose ≥ 126mg/dL and \< 240mg/dL at screening
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2.
Exclusion Criteria
* Serum creatinine \> upper limit of normal
* Proteinuria（albumin/creatinine ratio \> 300mg/g）
* Dysuria and/or urinary tract infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
20 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_CHAIR
Astellas Pharma Inc
Locations
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Kantou, , Japan
Countries
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References
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Toyoshima J, Saito M, Kaibara A, Isaka H, Sakatani T. Comparison of the Pharmacokinetic and Pharmacodynamic Relationship of Ipragliflozin Between Patients With Type 1 and Type 2 Diabetes Mellitus. Clin Ther. 2020 Sep;42(9):1787-1798.e3. doi: 10.1016/j.clinthera.2020.07.009. Epub 2020 Aug 21.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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1941-CL-0070
Identifier Type: -
Identifier Source: org_study_id
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