A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01071850
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
412 participants
INTERVENTIONAL
2010-03-03
2011-04-11
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
ASP1941 low dose
oral tablet
ipragliflozin
oral tablet
ASP1941 high dose
oral tablet
ipragliflozin
oral tablet
ASP1941 highest dose
oral tablet
ipragliflozin
oral tablet
Metformin
oral tablet
Metformin
oral tablet
Placebo
oral tablet
Placebo
oral tablet
Interventions
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ipragliflozin
oral tablet
Metformin
oral tablet
Placebo
oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has a HbA1c value between 6.8 and 9.5%
* Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
* Subject is on a stable diet and exercise program
* Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
Exclusion Criteria
* Subject is using insulin therapy
* Subject has a serum creatinine higher than upper limit of normal
* Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
* Subject has persistent, uncontrolled severe hypertension as indicated by a
systolic blood pressure \>180 mmHg or a diastolic blood pressure of
\>110mmHg
* Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
* Subject is known to have hepatitis or be a carrier of hepatitis B surface
antigen, hepatitis C virus antibody or is known positive for HIV1 and/or
HIV2
* Subject has a history of lactic acidosis
* Subject has a history of drug and alcohol abuse/dependency within last 12
months
* Subject has had a malignancy in the last 5 years, except for successfully
treated basal or squamous cell carcinoma of the skin or of the cervix
* Subject has a symptomatic urinary tract infection or genital infection
* Female subject is lactating
* Subject has an unstable medical or psychiatric illness
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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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Parkway Medical Center
Birmingham, Alabama, United States
Winston Technology Research, LLC
Haleyville, Alabama, United States
Desert Clinical Research
Mesa, Arizona, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Paul W. Davis, MD, PA
Pine Bluff, Arkansas, United States
Clinical Innovations, Inc.
Costa Mesa, California, United States
Del Rosario Medical Clinic, Inc
Huntington Park, California, United States
Torrance Clinical Research
Lomita, California, United States
San Diego Managed Care Group Clinical Research
San Diego, California, United States
Expresscare Clinical Research
Colorado Springs, Colorado, United States
PAB Clinical Research
Brandon, Florida, United States
Clinical Therapeutics Corp.
Coral Gables, Florida, United States
A.G.A Clinical Trials DBA Neostart Group
Hialeah, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
CSRA Partners in Health, Inc.
Augusta, Georgia, United States
Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
Tucker, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
APEX Medical Research, AMR, Inc
Chicago, Illinois, United States
MediSphere Medical Research
Evansville, Indiana, United States
Bay West Endocrinology
Towson, Maryland, United States
Prism Research
Saint Paul, Minnesota, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States
Rapid Medical Research
Cleveland, Ohio, United States
Primecare of Southeastern Ohio, Inc.
Zanesville, Ohio, United States
Integris Family Care
Yukon, Oklahoma, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
Fleetwood Clinical Research
Fleetwood, Pennsylvania, United States
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Southwind Medical Specialist
Memphis, Tennessee, United States
Punzi Medical Center
Carrollton, Texas, United States
Corpus Christi Family Wellness Center
Corpus Christi, Texas, United States
Excel Clinical Research, LLC
Houston, Texas, United States
Cetero Research
San Antonio, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
BIOMELAB
Barranquilla, , Colombia
Centro de Reumatologia y ortopedia
Barranquilla, , Colombia
Fundacion de Caribe para le Investigacion Biomedica
Barranquilla, , Colombia
Dexa Diad Servicios Medicos
Bogotá, , Colombia
School of Medicine University of Rosario
Bogotá, , Colombia
Fundacion Cardiovascular de Columbia
Floridablanca Santander, , Colombia
Diacon Hospital
Bangalore, , India
Hormone Care and Research Centre
Ghaziabad, , India
TOTALL Diabetes Hormone Institute Pvt.Ltd.
Indore, , India
S R Kalla Memorial Gastro & General Hospital
Jaipur, , India
Bride, Bharti Hospital
Karnāl, , India
Amrita Institute of Medical Sciences and Research Centre, AIMS
Kerala, , India
Unidad Metabólica y Cardiovascular, SC.
Cuernavaca, , Mexico
Instituto Jaliscience de Investigacion Clinica
Guadalajara, , Mexico
Torre Medica Providencia
Guadalajara, , Mexico
Medical Care and Research
Mérida, , Mexico
CEDIME, Instituto Vascular
Mérida, , Mexico
Hospital Universitario Dr. Eleuterio Gonzalez
Monterrey, , Mexico
Cebu Doctors' University Hospital
Cebu, , Philippines
St. Paul's Hospital
Iloilo City, , Philippines
Amang Rodriguez Memorial Medical Center
Marikina City, , Philippines
San Juan De Dios Hospital
Pasay, , Philippines
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.
Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complications. 2013 May-Jun;27(3):268-73. doi: 10.1016/j.jdiacomp.2012.11.005. Epub 2012 Dec 29.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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1941-CL-0004
Identifier Type: -
Identifier Source: org_study_id
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