A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01071850

Run by

Astellas Pharma Inc

People needed

412

Starts

2010-03-03

Expected to finish

2011-04-11

Last updated by the study team

2025-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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