Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.

Last updated: October 2, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetic Gastroparesis

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT02648204
NN9535-4216
U1111-1164-8495
2014-005375-91
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informedconsent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive)

  • Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximaltolerated dose documented in the patient medical record) for 90 days prior to screening

Exclusion

Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnantor is of child-bearing potential and not using an adequate contraceptive method (adequatecontraceptive measures as required by local regulation or practice) - Any condition, whichin the investigator's opinion might jeopardise subject's safety or compliance with theprotocol - Treatment with any medication for the indication of diabetes or obesity otherthan stated in the inclusion criteria in a period of 90 days before screening. An exceptionis short-term insulin treatment for acute illness for a total of equal to or below 14 days

  • History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or MedullaryThyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) -Subjects presently classified as being in New York Heart Association Class IV - Plannedcoronary, carotid or peripheral artery revascularisation on the day of screening -Proliferative retinopathy or maculopathy requiring acute treatment - History or presence ofmalignant neoplasms within the last 5 years (except basal and squamous cell skin cancer andin-situ carcinomas) - Anticipated initiation or change in concomitant medications (for morethan 14 consecutive days or on a frequent basis) known to affect weight or glucosemetabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Study Design

Total Participants: 1201
Study Start date:
January 06, 2016
Estimated Completion Date:
May 19, 2017

Connect with a study center

  • Novo Nordisk Investigational Site

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Burgas, 8000
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Montana, 3400
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1233
    Bulgaria

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  • Novo Nordisk Investigational Site

    Stara Zagora, 6000
    Bulgaria

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  • Novo Nordisk Investigational Site

    Karlovac, 47000
    Croatia

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  • Novo Nordisk Investigational Site

    Krapinske Toplice, 49217
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Rijeka, 51 000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Varazdin, 42 000
    Croatia

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  • Novo Nordisk Investigational Site

    Virovitica, 33000
    Croatia

    Site Not Available

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    Zagreb, 10 000
    Croatia

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  • Novo Nordisk Investigational Site

    Jyväskylä, 40100
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Kerava, FI-04200
    Finland

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    Kuusamo, 93600
    Finland

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    Raisio, 21200
    Finland

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  • Novo Nordisk Investigational Site

    Tampere, 33210
    Finland

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    Turku, 20520
    Finland

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    Dresden, 01219
    Germany

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  • Novo Nordisk Investigational Site

    Falkensee, 14612
    Germany

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    Friedrichsthal, 66299
    Germany

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    Hamburg, 22607
    Germany

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    Münster, 48145
    Germany

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    Rehlingen-Siersburg, 66780
    Germany

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    Saint Ingbert, 66386
    Germany

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    Saint Ingbert-Oberwürzbach, 66386
    Germany

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    St. Ingbert, 66386
    Germany

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    Athens, 115 25
    Greece

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    Chalkida, Evia, GR-34100
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    Ioannina, 45500
    Greece

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    Piraeus, GR-18536
    Greece

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    Pireaus, 18536
    Greece

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    Thessaloniki, GR-57010
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    Hong Kong,
    Hong Kong

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    Shatin, New Territories,
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    Guntur, Andhra Pradesh 522001
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    Hyderabad, Andhra Pradesh 500004
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    Visakhapatnam, Andhra Pradesh 530002
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    Guwahati, Assam 781008
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    Ahmedabad, Gujarat 380007
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    Bangalore, Karnataka 560002
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    Kochi, Kerala 682041
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    Kozhikode, Kerala 673017
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    Indore, Madhya Pradesh 452008
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    Goa, Maharashtra 403 202
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    Mumbai, Maharashtra 400008
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    Pune, Maharashtra 411040
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    Delhi, New Delhi 110002
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    New Dehli, New Delhi 110029
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    Bhubaneswar, Orissa 751005
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    Mohali, Punjab 160062
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    Chennai, Tamil Nadu 600086
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    Vellore, Tamil Nadu 632004
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    Kolkata, West Bengal 700017
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    Ludhiana, 141001
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    New Delhi, 110001
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    Dublin, DUBLIN 4
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    Galway, H91 YR71
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    Gorey,
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    Riga, LV-1038
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    Kaunas, 50009
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    Panevezys, 37355
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    Vilnius, 04318
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    Almada, 2805-267
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    Aveiro, 3814-501
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    Lisboa, 1250-230
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    Oradea, Bihor 410469
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    Targu Mures, Mures 540142
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    Galati, 800578
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    Piestany, 92101
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    Poprad, 05801
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    Prievidza, 97101
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    Alicante, 03010
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    Barcelona, 08430
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    La Roca del Vallés, 08430
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    Madrid, 28009
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    Palma de Mallorca, 07014
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    Segovia, 40002
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    Sevilla, 41010
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    Vic (Barcelona), 08500
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    Northwood, HA6 2RN
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    Romford, RM1 3PJ
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    Soham, CB7 5JD
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    Southampton, SO30 3JB
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    Stevenage, SG1 4AB
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    Watford, WD25 7NL
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  • Novo Nordisk Clinical Trial Call Center

    Muscle Shoals, Alabama 35662
    United States

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    Tuscumbia, Alabama 35674
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    Chandler, Arizona 85224
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    Glendale, Arizona 85301
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    Phoenix, Arizona 85050
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    Phoeniz, Arizona 85032
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    Anaheim, California 92801
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    Buena Park, California 90620
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    Carlsbad, California 92008
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    Chino, California 91710
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    Concord, California 94520
    United States

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    Hawaiian Gardens, California 90716
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    Huntington Park, California 90255
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    Lincoln, California 95648
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    Los Angeles, California 90057
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    Mission Hills, California 91405
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    Montclair, California 91763
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    Poway, California 92064
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    Riverside, California 92506
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    San Diego, California 92103
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    Tustin, California 92780
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    Van Nuys, California 91405
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  • Novo Nordisk Clinical Trial Call Center

    West Hills, California 91307
    United States

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    Denver, Colorado 80220
    United States

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    Norwalk, Connecticut 06851
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    Clearwater, Florida 33761
    United States

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    Coral Gables, Florida 33134
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    Edgewater, Florida 32132
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    Fort Lauderdale, Florida 33316
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    Kissimmee, Florida 34741
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    Miami, Florida 33173
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    Orlando, Florida 32804
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    Pembroke Pines, Florida 33027
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    Port Orange, Florida 32127
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    Tampa, Florida 33634
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    Adairsville, Georgia 30103
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    Atlanta, Georgia 30342
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    Bainbridge, Georgia 39819
    United States

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    Conyers, Georgia 30094-5965
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    Marietta, Georgia 30060
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    Suwanee, Georgia 30024
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    Meridian, Idaho 83646
    United States

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    Addison, Illinois 60101
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    Chicago, Illinois 60607
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    Gillespie, Illinois 62033
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    Gurnee, Illinois 60031
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    Peoria, Illinois 61602
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    Avon, Indiana 46123
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    Evansville, Indiana 47714
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    Greenfield, Indiana 46140
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    Indianapolis, Indiana 46254
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    Muncie, Indiana 47304
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    Newton, Kansas 67114
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    Park City, Kansas 67219
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    Covington, Kentucky 41011
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    Louisville, Kentucky 40213
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    Owensboro, Kentucky 42303
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    Hyattsville, Maryland 20782
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    Oxon Hill, Maryland 20745
    United States

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    Methuen, Massachusetts 01844
    United States

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    Rochester, Michigan 48307
    United States

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    Port Gibson, Mississippi 39150
    United States

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    Missoula, Montana 59808
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    Trenton, New Jersey 08611
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    New York, New York 10016
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    Garner, North Carolina 27529
    United States

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    Whiteville, North Carolina 28472
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    Winston-Salem, North Carolina 27103
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    Cincinnati, Ohio 45242
    United States

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  • Novo Nordisk Investigational Site

    Dayton, Ohio 45439
    United States

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  • Novo Nordisk Investigational Site

    Mason, Ohio 45040-6815
    United States

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  • Novo Nordisk Investigational Site

    Wadsworth, Ohio 44281-9236
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    Tulsa, Oklahoma 74136
    United States

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    Corvallis, Oregon 97330-3737
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    Fleetwood, Pennsylvania 19522
    United States

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    Harleysville, Pennsylvania 19438
    United States

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    Philadelphia, Pennsylvania 19114
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    Pittsburgh, Pennsylvania 15224-2215
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    Greer, South Carolina 29651
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    Moncks Corner, South Carolina 29461
    United States

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    Spartanburg, South Carolina 29303
    United States

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    Rapid City, South Dakota 57702
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    Humboldt, Tennessee 38343
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    Arlington, Texas 76015
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    Channelview, Texas 77530
    United States

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    Corpus Christi, Texas 78404
    United States

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    Dallas, Texas 75230
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    Houston, Texas 77025
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    Katy, Texas 77450
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    San Antonio, Texas 78231
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    Sugar Land, Texas 77479
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    Riverton, Utah 84065
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    Saint George, Utah 84790
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    St. George, Utah 84790
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    Spokane, Washington 99216-1557
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    Walla Walla, Washington 99362-4445
    United States

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    Wenatchee, Washington 98801-2028
    United States

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