A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
412
5 countries
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes-mellitus-type-2
Started Mar 2010
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 19, 2010
CompletedStudy Start
First participant enrolled
March 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2011
CompletedMay 22, 2025
May 1, 2025
1.1 years
February 18, 2010
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in Hemoglobin A1c (HbA1c)
12 weeks
Secondary Outcomes (3)
Mean change from baseline in fasting plasma glucose (FPG)
12 weeks
Proportion of subjects achieving target goal of HbA1c <7.0%
12 weeks
Proportion of subjects achieving target goal of HbA1c <6.5%
12 weeks
Study Arms (6)
ASP1941 lowest dose
EXPERIMENTALoral tablet
ASP1941 low dose
EXPERIMENTALoral tablet
ASP1941 high dose
EXPERIMENTALoral tablet
ASP1941 highest dose
EXPERIMENTALoral tablet
Metformin
ACTIVE COMPARATORoral tablet
Placebo
PLACEBO COMPARATORoral tablet
Interventions
oral tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Winston Technology Research, LLC
Haleyville, Alabama, 35565, United States
Desert Clinical Research
Mesa, Arizona, 85213, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Paul W. Davis, MD, PA
Pine Bluff, Arkansas, 71603, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92626, United States
Del Rosario Medical Clinic, Inc
Huntington Park, California, 90255, United States
Torrance Clinical Research
Lomita, California, 90717, United States
San Diego Managed Care Group Clinical Research
San Diego, California, 92128, United States
Expresscare Clinical Research
Colorado Springs, Colorado, 80909, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Clinical Therapeutics Corp.
Coral Gables, Florida, 33131, United States
A.G.A Clinical Trials DBA Neostart Group
Hialeah, Florida, 33012, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
CSRA Partners in Health, Inc.
Augusta, Georgia, 30909, United States
Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
Tucker, Georgia, 30084, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
APEX Medical Research, AMR, Inc
Chicago, Illinois, 60616, United States
MediSphere Medical Research
Evansville, Indiana, 47714, United States
Bay West Endocrinology
Towson, Maryland, 21204, United States
Prism Research
Saint Paul, Minnesota, 55114, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Primecare of Southeastern Ohio, Inc.
Zanesville, Ohio, 43701, United States
Integris Family Care
Yukon, Oklahoma, 73099, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522, United States
Southeastern Research Associates, Inc.
Taylors, South Carolina, 29687, United States
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Southwind Medical Specialist
Memphis, Tennessee, 38125, United States
Punzi Medical Center
Carrollton, Texas, 75006, United States
Corpus Christi Family Wellness Center
Corpus Christi, Texas, 78414, United States
Excel Clinical Research, LLC
Houston, Texas, 77081, United States
Cetero Research
San Antonio, Texas, 78229, United States
Aspen Clinical Research
Orem, Utah, 84058, 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, 560010, India
Hormone Care and Research Centre
Ghaziabad, 201002, India
TOTALL Diabetes Hormone Institute Pvt.Ltd.
Indore, 452001, India
S R Kalla Memorial Gastro & General Hospital
Jaipur, 302001, India
Bride, Bharti Hospital
Karnāl, 132001, India
Amrita Institute of Medical Sciences and Research Centre, AIMS
Kerala, 682041, India
Unidad Metabólica y Cardiovascular, SC.
Cuernavaca, 62250, Mexico
Instituto Jaliscience de Investigacion Clinica
Guadalajara, 44100, Mexico
Torre Medica Providencia
Guadalajara, 44670, Mexico
Medical Care and Research
Mérida, 97070, Mexico
CEDIME, Instituto Vascular
Mérida, 97129, Mexico
Hospital Universitario Dr. Eleuterio Gonzalez
Monterrey, 66460, Mexico
Cebu Doctors' University Hospital
Cebu, 6000, Philippines
St. Paul's Hospital
Iloilo City, 5000, Philippines
Amang Rodriguez Memorial Medical Center
Marikina City, 1800, Philippines
San Juan De Dios Hospital
Pasay, 1300, Philippines
Related Publications (2)
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.
PMID: 31606880DERIVEDFonseca 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.
PMID: 23276620DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2010
First Posted
February 19, 2010
Study Start
March 3, 2010
Primary Completion
April 11, 2011
Study Completion
April 11, 2011
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.