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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:11/23/2017
Start Date:March 3, 2010
End Date:April 11, 2011

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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 Subjects With Type 2 Diabetes Mellitus

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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Kingsport, Tennessee 37660
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5109 Medical Drive
San Antonio, Texas 78229
210-433-6222
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Augusta, Georgia 30909
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Barranquilla,
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Birmingham, Alabama 35215
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Brandon, Florida 33511
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Bristol, Tennessee 37620
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Carrollton, Texas 75006
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Charlotte, North Carolina 28209
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Chicago, Illinois 60607
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Chicago, Illinois 60616
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Cleveland, Ohio 44122
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Colorado Springs, Colorado 80909
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Coral Gables, Florida 33131
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5920 Saratoga Boulevard
Corpus Christi, Texas 78414
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Costa Mesa, California 92280
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Eugene, Oregon 97404
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Evansville, Indiana 47714
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805 North Richmond Street
Fleetwood, Pennsylvania 19522
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Haleyville, Alabama 35565
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Houston, Texas 77081
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Huntington Park, California 90255
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Lomita, California 90717
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Memphis, Tennessee 38125
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Mesa, Arizona 85201
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New Port Richey, Florida 34652
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Orem, Utah 84058
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Phoenix, Arizona 85020
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Pine Bluff, Arkansas 71603
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Saint Paul, Minnesota 55114
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Salisbury, North Carolina 28144
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San Diego, CA
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Taylors, South Carolina 29687
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6535 North Charles Street
Towson, Maryland 21204
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Tucker, GA
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1205 Health Center Parkway
Yukon, Oklahoma 73099
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Zanesville, Ohio 43701
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