A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01117584
Last Updated: 2025-05-22
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
343 participants
INTERVENTIONAL
2010-04-06
2011-04-01
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 lowest dose
oral tablet
ipragliflozin
oral tablet
Metformin
oral tablet
ASP1941 low dose
oral tablet
ipragliflozin
oral tablet
Metformin
oral tablet
ASP1941 high dose
oral tablet
ipragliflozin
oral tablet
Metformin
oral tablet
ASP1941 highest dose
oral tablet
ipragliflozin
oral tablet
Metformin
oral tablet
Placebo
oral tablet
Placebo
oral tablet
Metformin
oral tablet
Interventions
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ipragliflozin
oral tablet
Placebo
oral tablet
Metformin
oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has inadequate glycemic control indicated by an HbA1c level between 7.0% and 9.5% at start of the run-in period at Visit 1 AND does not meet any of the FPG discontinuation criteria
* Subject has been on a stable dose of at least 1500 mg/day metformin monotherapy for at least 6 weeks prior to Visit 1
* Subject is on a stable diet and exercise program (for at least 6 weeks prior to Visit 1) and is willing to remain on this program for the duration of the study
* Subject has a body mass index (BMI) 20 - 45 kg/m2 at Visit 1
* Female subject of childbearing potential has a negative serum pregnancy test (human chorionic gonadotropin \[hCG\]) at Visit 1 and agrees to use an acceptable form of contraception throughout the duration of the study OR is at least 1 year post-menopausal (defined as amenorrhea for at least 1 year) or surgically sterile. Male study subjects should be advised to use a male condom in addition to having their partner use another acceptable method during the study and for 3 months after the last dose
Exclusion Criteria
* Subject has type 1 diabetes mellitus
* Subject is in need of insulin therapy or has received insulin within 3 months prior to Visit 1, with the exception of acute use of \<7 days
* Subject has a serum creatinine higher than upper limit of normal range at Visit 1
* Subject has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than 3 times upper limit of normal range or has a total bilirubin more than 2 times upper limit of normal at Visit 1
* Subject has a urinary microalbumin/creatinine ratio above or equal to 300 mg/g at Visit 1
* Subject has a symptomatic urinary tract infection (UTI) or symptomatic genital infection at Visit 1 or during the placebo run-in period, including just prior to randomization at Visit 2
* Subject has persistent, uncontrolled severe hypertension as indicated by a systolic blood pressure \>180 mmHg or a diastolic blood pressure of \>110 mmHg taken in a sitting position after 5 minutes of rest on at least 2 measurements (within 30 minutes of each other) at Visit 1
* Subject has a significant cardiovascular disease, such as myocardial infarction or a vascular intervention (e.g. angioplasty or stent) within 3 months prior to Visit 1, or history of heart failure (New York Heart Association \[NYHA\] Class III IV)
* Subject is known to have hepatitis or be a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (enzyme linked immunosorbent assay \[ELISA\] plus confirmatory test), or is known positive for human immunodeficiency virus (HIV) HIV-1 and/or HIV 2
* Subject is currently receiving an excluded medication (loop-diuretics or systemic corticosteroids) or has received any other oral anti-diabetic drug except for metformin within 3 months prior to Visit 1
* Subject has history of lactic acidosis
* Subject has a history of drug or alcohol abuse/dependency within 12 months prior to Visit 1 as defined in the Diagnostic and Statistical Manual-IV (DSM-IV)
* Subject has had a malignancy in the last 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Female subject who is pregnant, lactating or pre-menopausal with positive serum pregnancy test (hCG) at Visit 1 or has an intention of becoming pregnant
* Subject has an unstable medical or psychiatric illness
* Subject has known or suspected hypersensitivity to ASP1941 or any components of the formulations used
* Subject has previously received ASP1941
* Subject is concurrently participating in another drug study or has received an investigational drug within 30 days (or the limit set by national law, whichever is longer) prior to Visit 1
* Subject has any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety or completion of this study
* In the investigator's judgment, the subject is unable to adhere to the treatment regimen, protocol procedures or study requirements
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Ude Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Los Angeles, California, United States
Coral Gables, Florida, United States
Hialeah, Florida, United States
Kissimmee, Florida, United States
Las Vegas, Nevada, United States
Baja, , Hungary
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Gyöngyös, , Hungary
Makó, , Hungary
Nyíregyháza, , Hungary
Zalaegerszeg, , Hungary
Ancona, , Italy
Milan, , Italy
Siena, , Italy
Chrzanów, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Kutno, , Poland
Lodz, , Poland
Lublin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Brasov, , Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Constanța, , Romania
Craiova, , Romania
Lasi, , Romania
Ploieşti, , Romania
Ploieşti, , Romania
Sibiu, , Romania
Sibiu, , Romania
Birmingham, , United Kingdom
Cambridgeshire, , United Kingdom
Manchester, , United Kingdom
Reading, , United Kingdom
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 website
Other Identifiers
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2009-013881-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1941-CL-0005
Identifier Type: -
Identifier Source: org_study_id
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