Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 77
Updated:10/14/2017
Start Date:August 2005
End Date:February 2010

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Trial Summary
Trial Overview
Inclusion Criteria

"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"

The purpose of this clinical research study is to learn whether Saxagliptin added to
Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic
subjects who are not sufficiently controlled with Metformin alone

All subjects will participate in a lead-in period, and qualifying subjects will continue into
a short-term randomized treatment period. Subjects who complete the short-term period will be
eligible to enter the long term extension period. Also, subjects in the short-term period who
have an elevated blood sugar that requires additional medication for blood sugar control will
be eligible to enter the long-term treatment extension period where they will receive
pioglitizone added onto their blinded study medication

Inclusion Criteria:

- Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater
than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks
prior to screening.

- HbA1c >= 7.0% and <= 10.0 %

- Body mass index <= 40 kg/m2

- Fasting C-peptide >= 1 ng/dL

Exclusion Criteria:

- Symptomatic poorly controlled diabetes

- Recent cardiac or cerebrovascular event

- Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females
We found this trial at
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Tallahassee, Florida 32308
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Albuquerque, New Mexico 87108
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773 Douglas Avenue
Altamonte Springs, Florida 32714
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1821 Mc Call Drive
Anniston, Alabama 36207
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Athens, Ohio 45701
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Austin, Texas 78701
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Baltimore, Maryland 21237
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Birmingham, Alabama 35294
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Boston, Massachusetts 02111
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Bristol, Tennessee 37620
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3100 Texas 47
Bryan, Texas 77807
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100 Calera Eagle Drive
Calera, Alabama 35040
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49 Brookwood Avenue
Carlisle, Pennsylvania 17015
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1925 East Belt Line Road
Carrollton, Texas 75006
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5254 North Meadows Drive
Castle Rock, Colorado 80109
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Charleston, South Carolina 29425
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Charlotte, North Carolina 28203
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Chester, Maryland
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Chicago, Illinois 60637
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1331 South Blvd
Chipley, Florida 32428
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3300 North Atlantic Avenue
Cocoa Beach, Florida 32931
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Colorado Springs, Colorado 80910
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Columbus, Ohio 43219
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Coral Gables, Florida 33134
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Dallas, Texas 75246
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2675 North Decatur Road
Decatur, Georgia 30033
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Denver, Colorado 80220
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100 South Danzler Road
Duncan, South Carolina 29334
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2608 California Road
Elkhart, Indiana 46514
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5535 Balboa Boulevard
Encino, California 91316
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868 High Street
Eugene, Oregon 97401
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Fort Lauderdale, Florida 33309
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Fountain Valley, California
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Fresno, California 93720
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Golden, Colorado 80401
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Greensboro, North Carolina 27405
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2001 20th Street
Haleyville, Alabama 35565
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100 East Queen Street
Hampton, Virginia 23668
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Houston, Texas 77030
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Iowa City, Iowa 52242
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Jacksonville, Florida 32256
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2405 Aggie Road
Jonesboro, Arkansas 72401
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200 Commons Way
Kalispell, Montana 59901
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Kansas City, Missouri 64108
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4727 West Irlo Bronson Memorial Highway
Kissimmee, Florida 34746
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1400 Teal Road West
Lafayette, Indiana 47905
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Langhorne, Pennsylvania 19047
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Las Vegas, Nevada 89106
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2019 Edgely Road
Levittown, Pennsylvania 19057
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Lexington, Kentucky 40536
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Little Rock, Arkansas 72201
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Los Angeles, California 90095
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1900 North Boise Avenue
Loveland, Colorado 80538
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1876 South Green Road
Lyndhurst, Ohio 44121
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3350 Deán Funes
Mar Del Plata, Buenos Aires B7602
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3625 F C I Road
Marianna, Florida 32446
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Mesa, Arizona 85206
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Miami, Florida 33136
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26726 Crown Valley Parkway
Mission Viejo, California 92691
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3431 Arendell Street
Morehead City, North Carolina 28557
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Munfordville, Kentucky
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New Orleans, Louisiana 70118
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New Port Richey, Florida 34652
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18250 Roscoe Boulevard
Northridge, California 91325
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Ocala, Florida 34474
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Oklahoma City, Oklahoma 73103
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1620 4th Avenue East
Olympia, Washington 98506
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Omaha, Nebraska 68114
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Orange, California 92868
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Philadelphia, Pennsylvania 19102
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Phoenix, Arizona 85016
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Pittsburgh, Pennsylvania 15240
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Portland, Oregon 97201
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850 Costley Way
Prince Frederick, Maryland 20678
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Roseville, California 95678
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Sacramento, California 95819
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Salisbury, North Carolina 28144
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Salt Lake City, Utah 84132
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San Antonio, Texas 78229
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6929 J.F.K. Boulevard
Sherwood, Arkansas 72116
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404 Trojan Avenue
Sparta, North Carolina 28675
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Spokane, Washington 99216
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3230 Sweetwater Springs Boulevard
Spring Valley, California 91977
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St. Louis, Missouri 63110
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Tampa, Florida 33612
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Temple, Texas 76508
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2363 Lakewood Road
Toms River, New Jersey 08755
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3107 Southwest 21st Street
Topeka, Kansas 66604
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Tulsa, Oklahoma 74136
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17632 Irvine Boulevard
Tustin, California 92780
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145 Lakeview Parkway
Vernon Hills, Illinois 60061
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4500 Main Street
Virginia Beach, Virginia 23462
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Waterloo, Iowa 50702
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501 Natchitoches Street
West Monroe, Louisiana 71291
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Wilmington, North Carolina 28401
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Winston Salem, North Carolina 27103
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