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
sites
Local Institution
Baltimore, Maryland 21237
349
mi
from 43215
Baltimore, MD
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Albuquerque, New Mexico 87108
1330
mi
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Albuquerque, NM
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773 Douglas Avenue
Altamonte Springs, Florida 32714
785
mi
from 43215
Altamonte Springs, FL
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1821 Mc Call Drive
Anniston, Alabama 36207
461
mi
from 43215
Anniston, AL
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Local Institution
Athens, Ohio 45701
65
mi
from 43215
Athens, OH
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Local Institution
Austin, Texas 78701
1065
mi
from 43215
Austin, TX
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Local Institution
Birmingham, Alabama 35294
492
mi
from 43215
Birmingham, AL
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Boston, Massachusetts 02111
643
mi
from 43215
Boston, MA
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Local Institution
Bristol, Tennessee 37620
237
mi
from 43215
Bristol, TN
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3100 Texas 47
Bryan, Texas 77807
992
mi
from 43215
Bryan, TX
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Local Institution
100 Calera Eagle Drive
Calera, Alabama 35040
518
mi
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Calera, AL
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49 Brookwood Avenue
Carlisle, Pennsylvania 17015
307
mi
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Carlisle, PA
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1925 East Belt Line Road
Carrollton, Texas 75006
908
mi
from 43215
Carrollton, TX
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Local Institution
5254 North Meadows Drive
Castle Rock, Colorado 80109
1160
mi
from 43215
Castle Rock, CO
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Local Institution
Charleston, South Carolina 29425
524
mi
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Charleston, SC
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Local Institution
Charlotte, North Carolina 28203
348
mi
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Charlotte, NC
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Local Institution
Chester, Maryland
365
mi
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Chester, MD
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Chicago, Illinois 60637
270
mi
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Chicago, IL
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1331 South Blvd
Chipley, Florida 32428
650
mi
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Chipley, FL
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Local Institution
3300 North Atlantic Avenue
Cocoa Beach, Florida 32931
814
mi
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Cocoa Beach, FL
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Colorado Springs, Colorado 80910
1163
mi
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Colorado Springs, CO
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Local Institution
Columbus, Ohio 43219
7
mi
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Columbus, OH
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Local Institution
Coral Gables, Florida 33134
994
mi
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Coral Gables, FL
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Local Institution
Dallas, Texas 75246
909
mi
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Dallas, TX
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Local Institution
2675 North Decatur Road
Decatur, Georgia 30033
432
mi
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Decatur, GA
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Local Institution
Denver, Colorado 80220
1158
mi
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Denver, CO
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Local Institution
100 South Danzler Road
Duncan, South Carolina 29334
351
mi
from 43215
Duncan, SC
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Local Institution
2608 California Road
Elkhart, Indiana 46514
196
mi
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Elkhart, IN
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Local Institution
5535 Balboa Boulevard
Encino, California 91316
1982
mi
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Encino, CA
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Local Institution
868 High Street
Eugene, Oregon 97401
2055
mi
from 43215
Eugene, OR
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Local Institution
Fort Lauderdale, Florida 33309
970
mi
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Fort Lauderdale, FL
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Local Institution
Fountain Valley, California
1966
mi
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Fountain Valley, CA
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Local Institution
Fresno, California 93720
1986
mi
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Fresno, CA
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Local Institution
Golden, Colorado 80401
1171
mi
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Golden, CO
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Local Institution
Greensboro, North Carolina 27405
321
mi
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Greensboro, NC
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Local Institution
2001 20th Street
Haleyville, Alabama 35565
470
mi
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Haleyville, AL
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Local Institution
100 East Queen Street
Hampton, Virginia 23668
414
mi
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Hampton, VA
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Local Institution
Houston, Texas 77030
995
mi
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Houston, TX
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Local Institution
Iowa City, Iowa 52242
459
mi
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Iowa City, IA
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Local Institution
Jacksonville, Florida 32256
678
mi
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Jacksonville, FL
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2405 Aggie Road
Jonesboro, Arkansas 72401
504
mi
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Jonesboro, AR
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Local Institution
200 Commons Way
Kalispell, Montana 59901
1641
mi
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Kalispell, MT
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Local Institution
Kansas City, Missouri 64108
619
mi
from 43215
Kansas City, MO
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Local Institution
4727 West Irlo Bronson Memorial Highway
Kissimmee, Florida 34746
809
mi
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Kissimmee, FL
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1400 Teal Road West
Lafayette, Indiana 47905
205
mi
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Lafayette, IN
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Langhorne, Pennsylvania 19047
428
mi
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Langhorne, PA
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Local Institution
Las Vegas, Nevada 89106
1757
mi
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Las Vegas, NV
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Local Institution
2019 Edgely Road
Levittown, Pennsylvania 19057
432
mi
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Levittown, PA
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Local Institution
Lexington, Kentucky 40536
155
mi
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Lexington, KY
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Local Institution
Little Rock, Arkansas 72201
622
mi
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Little Rock, AR
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Local Institution
Los Angeles, California 90095
1982
mi
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Los Angeles, CA
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Local Institution
1900 North Boise Avenue
Loveland, Colorado 80538
1159
mi
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Loveland, CO
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1876 South Green Road
Lyndhurst, Ohio 44121
132
mi
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Lyndhurst, OH
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3350 Deán Funes
Mar Del Plata, Buenos Aires B7602
5622
mi
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Mar Del Plata,
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3625 F C I Road
Marianna, Florida 32446
642
mi
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Marianna, FL
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Local Institution
Mesa, Arizona 85206
1650
mi
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Mesa, AZ
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Local Institution
Miami, Florida 33136
992
mi
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Miami, FL
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Local Institution
26726 Crown Valley Parkway
Mission Viejo, California 92691
1954
mi
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Mission Viejo, CA
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Local Institution
3431 Arendell Street
Morehead City, North Carolina 28557
499
mi
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Morehead City, NC
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Local Institution
Munfordville, Kentucky
242
mi
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Munfordville, KY
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Local Institution
New Orleans, Louisiana 70118
799
mi
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New Orleans, LA
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Local Institution
New Port Richey, Florida 34652
809
mi
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New Port Richey, FL
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Local Institution
18250 Roscoe Boulevard
Northridge, California 91325
1983
mi
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Northridge, CA
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Local Institution
Ocala, Florida 34474
748
mi
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Ocala, FL
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Local Institution
Oklahoma City, Oklahoma 73103
849
mi
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Oklahoma City, OK
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Local Institution
1620 4th Avenue East
Olympia, Washington 98506
2032
mi
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Olympia, WA
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Local Institution
Omaha, Nebraska 68114
688
mi
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Omaha, NE
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Local Institution
Orange, California 92868
1958
mi
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Orange, CA
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Local Institution
Philadelphia, Pennsylvania 19102
416
mi
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Philadelphia, PA
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Phoenix, Arizona 85016
1658
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Pittsburgh, Pennsylvania 15240
169
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Portland, Oregon 97201
2027
mi
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850 Costley Way
Prince Frederick, Maryland 20678
357
mi
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Prince Frederick, MD
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548 Gibson Drive
Roseville, California 95678
2028
mi
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Roseville, CA
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Sacramento, California 95819
2041
mi
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Sacramento, CA
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Salisbury, North Carolina 28144
327
mi
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Salisbury, NC
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Salt Lake City, Utah 84132
1510
mi
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Salt Lake City, UT
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San Antonio, Texas 78229
1138
mi
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San Antonio, TX
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Local Institution
6929 J.F.K. Boulevard
Sherwood, Arkansas 72116
617
mi
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Sherwood, AR
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Local Institution
404 Trojan Avenue
Sparta, North Carolina 28675
259
mi
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Sparta, NC
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Spokane, Washington 99216
1769
mi
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Spokane, WA
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3230 Sweetwater Springs Boulevard
Spring Valley, California 91977
1941
mi
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Spring Valley, CA
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St. Louis, Missouri 63110
397
mi
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St. Louis, MO
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Tallahassee, Florida 32308
662
mi
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Tallahassee, FL
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Local Institution
Tampa, Florida 33612
823
mi
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Tampa, FL
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Temple, Texas 76508
1011
mi
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Temple, TX
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2363 Lakewood Road
Toms River, New Jersey 08755
465
mi
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Toms River, NJ
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Local Institution
3107 Southwest 21st Street
Topeka, Kansas 66604
679
mi
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Topeka, KS
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Tulsa, Oklahoma 74136
752
mi
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Tulsa, OK
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Local Institution
17632 Irvine Boulevard
Tustin, California 92780
1958
mi
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Tustin, CA
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Local Institution
145 Lakeview Parkway
Vernon Hills, Illinois 60061
300
mi
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Vernon Hills, IL
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4500 Main Street
Virginia Beach, Virginia 23462
430
mi
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Virginia Beach, VA
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Local Institution
Waterloo, Iowa 50702
512
mi
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Waterloo, IA
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501 Natchitoches Street
West Monroe, Louisiana 71291
722
mi
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West Monroe, LA
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Local Institution
Wilmington, North Carolina 28401
485
mi
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Wilmington, NC
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Local Institution
Winston Salem, North Carolina 27103
307
mi
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Winston Salem, NC
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