A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01071850
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 412
- Subject has been diagnosed with type 2 diabetes
- 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
- Subject has type 1 diabetes mellitus
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP1941 lowest dose ipragliflozin oral tablet ASP1941 low dose ipragliflozin oral tablet ASP1941 high dose ipragliflozin oral tablet Placebo Placebo oral tablet ASP1941 highest dose ipragliflozin oral tablet Metformin Metformin oral tablet
- Primary Outcome Measures
Name Time Method Mean change from baseline in Hemoglobin A1c (HbA1c) 12 weeks
- Secondary Outcome Measures
Name Time Method Proportion of subjects achieving target goal of HbA1c <7.0% 12 weeks Proportion of subjects achieving target goal of HbA1c <6.5% 12 weeks Mean change from baseline in fasting plasma glucose (FPG) 12 weeks
Trial Locations
- Locations (59)
CSRA Partners in Health, Inc.
🇺🇸Augusta, Georgia, United States
Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
🇺🇸Tucker, Georgia, United States
Bride, Bharti Hospital
🇮🇳Karnal, India
Diacon Hospital
🇮🇳Bangalore, India
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Winston Technology Research, LLC
🇺🇸Haleyville, Alabama, United States
Desert Clinical Research
🇺🇸Mesa, Arizona, United States
Paul W. Davis, MD, PA
🇺🇸Pine Bluff, Arkansas, United States
Clinical Innovations, Inc.
🇺🇸Costa Mesa, California, United States
Expresscare Clinical Research
🇺🇸Colorado Springs, Colorado, United States
Torrance Clinical Research
🇺🇸Lomita, California, United States
Clinical Therapeutics Corp.
🇺🇸Coral Gables, Florida, United States
Del Rosario Medical Clinic, Inc
🇺🇸Huntington Park, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
A.G.A Clinical Trials DBA Neostart Group
🇺🇸Hialeah, Florida, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, 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 Salisbury, LLC
🇺🇸Salisbury, North Carolina, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Integris Family Care
🇺🇸Yukon, Oklahoma, United States
Willamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
Primecare of Southeastern Ohio, Inc.
🇺🇸Zanesville, Ohio, United States
PMG Research of Bristol, LLC
🇺🇸Bristol, Tennessee, United States
Fleetwood Clinical Research
🇺🇸Fleetwood, Pennsylvania, United States
Southeastern Research Associates, Inc.
🇺🇸Taylors, South Carolina, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Southwind Medical Specialist
🇺🇸Memphis, Tennessee, United States
Corpus Christi Family Wellness Center
🇺🇸Corpus Christi, Texas, United States
Punzi Medical Center
🇺🇸Carrollton, Texas, United States
Hormone Care and Research Centre
🇮🇳Ghaziabad, India
Fundacion de Caribe para le Investigacion Biomedica
🇨🇴Barranquilla, Colombia
School of Medicine University of Rosario
🇨🇴Bogota, Colombia
Centro de Reumatologia y ortopedia
🇨🇴Barranquilla, Colombia
Aspen Clinical Research
🇺🇸Orem, Utah, United States
BIOMELAB
🇨🇴Barranquilla, Colombia
Dexa Diad Servicios Medicos
🇨🇴Bogota, Colombia
Fundacion Cardiovascular de Columbia
🇨🇴Floridablanca Santander, Colombia
TOTALL Diabetes Hormone Institute Pvt.Ltd.
🇮🇳Indore, India
S R Kalla Memorial Gastro & General Hospital
🇮🇳Jaipur, 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
🇲🇽Merida, Mexico
CEDIME, Instituto Vascular
🇲🇽Merida, Mexico
Cebu Doctors' University Hospital
🇵🇭Cebu, Philippines
Hospital Universitario Dr. Eleuterio Gonzalez
🇲🇽Monterrey, Mexico
St. Paul's Hospital
🇵🇭Iloilo City, Philippines
Amang Rodriguez Memorial Medical Center
🇵🇭Marikina City, Philippines
San Juan De Dios Hospital
🇵🇭Pasay City, Philippines
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
San Diego Managed Care Group Clinical Research
🇺🇸San Diego, California, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Excel Clinical Research, LLC
🇺🇸Houston, Texas, United States
Cetero Research
🇺🇸San Antonio, Texas, United States