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
96
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Local Institution
Austin, Texas 78701
1211
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Austin, TX
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Albuquerque, New Mexico 87108
653
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Albuquerque, NM
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773 Douglas Avenue
Altamonte Springs, Florida 32714
2180
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Altamonte Springs, FL
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1821 Mc Call Drive
Anniston, Alabama 36207
1839
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Anniston, AL
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Athens, Ohio 45701
2008
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Athens, OH
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Baltimore, Maryland 21237
2307
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Birmingham, Alabama 35294
1785
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Birmingham, AL
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Boston, Massachusetts 02111
2578
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Boston, MA
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Bristol, Tennessee 37620
2015
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Bristol, TN
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3100 Texas 47
Bryan, Texas 77807
1277
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Bryan, TX
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100 Calera Eagle Drive
Calera, Alabama 35040
1792
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Calera, AL
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49 Brookwood Avenue
Carlisle, Pennsylvania 17015
2266
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Carlisle, PA
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1925 East Belt Line Road
Carrollton, Texas 75006
1217
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Carrollton, TX
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5254 North Meadows Drive
Castle Rock, Colorado 80109
813
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Castle Rock, CO
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Charleston, South Carolina 29425
2183
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Charleston, SC
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Charlotte, North Carolina 28203
2100
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Chester, Maryland
2320
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Chester, MD
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Chicago, Illinois 60637
1730
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1331 South Blvd
Chipley, Florida 32428
1899
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3300 North Atlantic Avenue
Cocoa Beach, Florida 32931
2232
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Colorado Springs, Colorado 80910
802
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Columbus, Ohio 43219
1965
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Coral Gables, Florida 33134
2318
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Coral Gables, FL
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Dallas, Texas 75246
1225
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2675 North Decatur Road
Decatur, Georgia 30033
1924
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Decatur, GA
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Denver, Colorado 80220
821
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Denver, CO
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100 South Danzler Road
Duncan, South Carolina 29334
2033
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Duncan, SC
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2608 California Road
Elkhart, Indiana 46514
1810
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Elkhart, IN
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5535 Balboa Boulevard
Encino, California 91316
28
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Encino, CA
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868 High Street
Eugene, Oregon 97401
740
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Eugene, OR
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Fort Lauderdale, Florida 33309
2315
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Fountain Valley, California
25
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Fountain Valley, CA
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Fresno, California 93720
216
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Fresno, CA
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Golden, Colorado 80401
809
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Greensboro, North Carolina 27405
2151
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2001 20th Street
Haleyville, Alabama 35565
1732
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100 East Queen Street
Hampton, Virginia 23668
2333
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Hampton, VA
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Houston, Texas 77030
1357
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Houston, TX
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Iowa City, Iowa 52242
1529
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Iowa City, IA
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Jacksonville, Florida 32256
2138
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2405 Aggie Road
Jonesboro, Arkansas 72401
1547
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200 Commons Way
Kalispell, Montana 59901
995
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Kansas City, Missouri 64108
1340
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4727 West Irlo Bronson Memorial Highway
Kissimmee, Florida 34746
2184
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1400 Teal Road West
Lafayette, Indiana 47905
1757
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Langhorne, Pennsylvania 19047
2387
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Las Vegas, Nevada 89106
217
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2019 Edgely Road
Levittown, Pennsylvania 19057
2391
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Lexington, Kentucky 40536
1881
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Little Rock, Arkansas 72201
1463
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Los Angeles, California 90095
24
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1900 North Boise Avenue
Loveland, Colorado 80538
835
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1876 South Green Road
Lyndhurst, Ohio 44121
2041
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3350 Deán Funes
Mar Del Plata, Buenos Aires B7602
6309
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Mar Del Plata,
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3625 F C I Road
Marianna, Florida 32446
1918
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Mesa, Arizona 85206
358
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Miami, Florida 33136
2321
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26726 Crown Valley Parkway
Mission Viejo, California 92691
40
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3431 Arendell Street
Morehead City, North Carolina 28557
2335
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Munfordville, Kentucky
1807
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New Orleans, Louisiana 70118
1653
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New Port Richey, Florida 34652
2114
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18250 Roscoe Boulevard
Northridge, California 91325
31
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Ocala, Florida 34474
2123
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Oklahoma City, Oklahoma 73103
1165
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1620 4th Avenue East
Olympia, Washington 98506
931
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Omaha, Nebraska 68114
1295
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Orange, California 92868
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Philadelphia, Pennsylvania 19102
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Phoenix, Arizona 85016
345
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Pittsburgh, Pennsylvania 15240
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Portland, Oregon 97201
827
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850 Costley Way
Prince Frederick, Maryland 20678
2306
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548 Gibson Drive
Roseville, California 95678
372
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Sacramento, California 95819
364
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Salisbury, North Carolina 28144
2117
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Salt Lake City, Utah 84132
573
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San Antonio, Texas 78229
1182
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6929 J.F.K. Boulevard
Sherwood, Arkansas 72116
1465
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404 Trojan Avenue
Sparta, North Carolina 28675
2074
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Spokane, Washington 99216
940
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3230 Sweetwater Springs Boulevard
Spring Valley, California 91977
110
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St. Louis, Missouri 63110
1570
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Tallahassee, Florida 32308
1977
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Tampa, Florida 33612
2134
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Temple, Texas 76508
1217
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Temple, TX
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2363 Lakewood Road
Toms River, New Jersey 08755
2424
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3107 Southwest 21st Street
Topeka, Kansas 66604
1280
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Tulsa, Oklahoma 74136
1250
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17632 Irvine Boulevard
Tustin, California 92780
24
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145 Lakeview Parkway
Vernon Hills, Illinois 60061
1717
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Vernon Hills, IL
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4500 Main Street
Virginia Beach, Virginia 23462
2345
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Waterloo, Iowa 50702
1502
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501 Natchitoches Street
West Monroe, Louisiana 71291
1495
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West Monroe, LA
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Wilmington, North Carolina 28401
2275
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Winston Salem, North Carolina 27103
2122
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Winston Salem, NC
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