A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
NCT ID: NCT01505426
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
PHASE3
171 participants
INTERVENTIONAL
2011-11-28
2013-01-14
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 group
ASP1941 + metformin
ASP1941
oral
metformin
oral, concomitant use
placebo group
placebo + metformin
metformin
oral, concomitant use
Placebo
oral
Interventions
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ASP1941
oral
metformin
oral, concomitant use
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable diet and exercise program for at least 8 weeks before the study
* On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
* BMI of 20.0 to 45.0 kg/m2
* A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose
Exclusion Criteria
* Proliferative diabetic retinopathy
* Receiving insulin within 12 weeks prior to the study
* History of clinically significant renal disease(s)
* Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
* Urinary tract infection or genital infection
* Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
* History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
* Severe infection, serious trauma, or perioperative subject
* Known or suspected hypersensitivity to ASP1941
* History of treatment with ASP1941
* Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
* Serum creatinine value exceeding the upper limit of normal range
* Urinary microalbumin/urinary creatinine ratio \>300 mg/g
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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Busan, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Gwangju, , South Korea
Incheon, , South Korea
Jeonju, , South Korea
Seoul, , South Korea
Wŏnju, , South Korea
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Countries
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References
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Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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1941-CL-2004
Identifier Type: -
Identifier Source: org_study_id
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