A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes

Last updated: April 30, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Kidney Disease

Diabetic Macular Edema

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT02030600
NN1250-3998
U1111-1143-7963
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides 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 - Subjects fulfilling at least one of the below criteria: a) Experienced at leastone severe hypoglycaemic episode within last year (according to the ADA (American DiabetesAssociation) definition, April 2013), b) Moderate chronic renal failure, defined asglomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (Chronic Kidney DiseaseEpidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptomunawareness, d) Exposed to insulin for more than 5 years, e) Recent episode ofhypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucosemeasurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for atleast 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ±any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor,thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 Forsubjects on BID the total daily dose should be below 75 units - HbA1c (glycosylatedhaemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index)

Exclusion

below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separatelyor contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use ofany other anti-diabetic agent(s) than those stated in the inclusion criteria within thelast 26 weeks prior to Visit 1

Study Design

Total Participants: 721
Study Start date:
January 06, 2014
Estimated Completion Date:
December 04, 2015

Connect with a study center

  • Novo Nordisk Investigational Site

    Carolina, 00983
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Manati, 00674
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Ponce, 00717
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35215-7502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Haleyville, Alabama 35565-1719
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Hamilton, Alabama 35570
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Montgomery, Alabama 36106
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Muscle Shoals, Alabama 35662
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tuscumbia, Alabama 35674
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85050
    United States

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  • Novo Nordisk Investigational Site

    Tucson, Arizona 85704
    United States

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  • Novo Nordisk Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Chino, California 91710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Downey, California 90242
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    El Cajon, California 92020
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Fair Oaks, California 95628
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fresno, California 93702
    United States

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  • Novo Nordisk Investigational Site

    Hawaiian Gardens, California 90716
    United States

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  • Novo Nordisk Investigational Site

    Huntington Park, California 90255
    United States

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  • Novo Nordisk Investigational Site

    Huntinton Park, California 90255
    United States

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  • Novo Nordisk Investigational Site

    Lincoln, California 95648
    United States

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  • Novo Nordisk Investigational Site

    Long Beach, California 90807
    United States

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  • Novo Nordisk Investigational Site

    Montclair, California 91763
    United States

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  • Novo Nordisk Investigational Site

    North Hollywood, California 91606
    United States

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    Northridge, California 91325
    United States

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    Pomona, California 91766-2007
    United States

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    Poway, California 92064
    United States

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    Rancho Cucamonga, California 91730-3063
    United States

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    Rialto, California 92376
    United States

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    Roseville, California 95661
    United States

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    San Diego, California 92111
    United States

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    Santa Monica, California 90404
    United States

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    Tarzana, California 91356-3551
    United States

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    Torrance, California 90502
    United States

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    Tustin, California 92780
    United States

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    Colorado Springs, Colorado 80910
    United States

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    Golden, Colorado 80401
    United States

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    Newark, Delaware 19713
    United States

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  • Novo Nordisk Investigational Site

    Bradenton, Florida 34201
    United States

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  • Novo Nordisk Investigational Site

    Chiefland, Florida 32626
    United States

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    Clearwater, Florida 33765
    United States

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    Cooper City, Florida 33024
    United States

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  • Novo Nordisk Investigational Site

    Doral, Florida 33166
    United States

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  • Novo Nordisk Clinical Trial Call Center

    Fleming Island, Florida 32203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hialeah, Florida 33013
    United States

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  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32277
    United States

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    Miami, Florida 33186
    United States

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  • Novo Nordisk Investigational Site

    Miami Springs, Florida 33166
    United States

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    Miramar, Florida 33027
    United States

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  • Novo Nordisk Investigational Site

    New Port Richey, Florida 34652
    United States

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    Ocala, Florida 34470
    United States

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    Orlando, Florida 32801
    United States

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    Panama City, Florida 32401
    United States

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  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida 33026
    United States

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  • Novo Nordisk Investigational Site

    Tampa, Florida 33619
    United States

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  • Novo Nordisk Investigational Site

    Perry, Georgia 31069
    United States

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  • Novo Nordisk Investigational Site

    Champaign, Illinois 61821
    United States

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    Chicago, Illinois 60611
    United States

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  • Novo Nordisk Investigational Site

    Evansville, Indiana 47714
    United States

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    Muncie, Indiana 47304
    United States

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    Des Moines, Iowa 50314-2610
    United States

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  • Novo Nordisk Investigational Site

    West Des Moines, Iowa 50265
    United States

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  • Novo Nordisk Investigational Site

    Lenexa, Kansas 66219
    United States

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    Newton, Kansas 67114
    United States

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    Lexington, Kentucky 40502
    United States

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    Louisville, Kentucky 40213
    United States

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    Paducah, Kentucky 42003
    United States

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    New Orleans, Louisiana 70119
    United States

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    Shreveport, Louisiana 71105
    United States

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  • Novo Nordisk Investigational Site

    Brockton, Massachusetts 02301
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  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan 49009
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    Olive Branch, Mississippi 38654-3573
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  • Novo Nordisk Investigational Site

    Florissant, Missouri 63031
    United States

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  • Novo Nordisk Investigational Site

    Jefferson City, Missouri 65109
    United States

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  • Novo Nordisk Investigational Site

    Kansas City, Missouri 64106
    United States

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  • Novo Nordisk Investigational Site

    Henderson, Nevada 89052-2649
    United States

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  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89148
    United States

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    Newington, New Hampshire 03801
    United States

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    Morganville, New Jersey 07751
    United States

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  • Novo Nordisk Investigational Site

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Wall, New Jersey 07719
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico 87102
    United States

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  • Novo Nordisk Investigational Site

    Albany, New York 12208
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    Jackson Heights, New York 11372
    United States

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    New Windsor, New York 12553
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    Northport, New York 11768
    United States

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    Smithtown, New York 11787
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    Charlotte, North Carolina 28277
    United States

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  • Novo Nordisk Investigational Site

    Morganton, North Carolina 28655
    United States

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  • Novo Nordisk Investigational Site

    Winston Salem, North Carolina 27103
    United States

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  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina 27103
    United States

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  • Novo Nordisk Investigational Site

    Delaware, Ohio 43015
    United States

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    Franklin, Ohio 45005
    United States

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  • Novo Nordisk Investigational Site

    Toledo, Ohio 43614
    United States

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  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73103
    United States

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  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania 16602
    United States

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  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania 15009
    United States

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    Philadelphia, Pennsylvania 19107
    United States

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    Scottdale, Pennsylvania 15683
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Tipton, Pennsylvania 16684
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gaffney, South Carolina 29341
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pelzer, South Carolina 29669
    United States

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  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina 29303
    United States

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  • Novo Nordisk Investigational Site

    Rapid City, South Dakota 57701
    United States

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  • Novo Nordisk Investigational Site

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404
    United States

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  • Novo Nordisk Investigational Site

    Humboldt, Tennessee 38343
    United States

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  • Novo Nordisk Investigational Site

    Jackson, Tennessee 38305
    United States

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  • Novo Nordisk Investigational Site

    Johnson City, Tennessee 37604
    United States

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  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

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  • Novo Nordisk Investigational Site

    Arlington, Texas 76012-4637
    United States

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  • Novo Nordisk Investigational Site

    Austin, Texas 78758
    United States

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  • Novo Nordisk Investigational Site

    Carrollton, Texas 75007
    United States

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  • Novo Nordisk Investigational Site

    Dallas, Texas 75208
    United States

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  • Novo Nordisk Investigational Site

    El Paso, Texas 79912
    United States

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  • Novo Nordisk Investigational Site

    Fort Worth, Texas 76104
    United States

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  • Novo Nordisk Investigational Site

    Houston, Texas 77070
    United States

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  • Novo Nordisk Investigational Site

    Humble, Texas 77338
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hurst, Texas 76054
    United States

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  • Novo Nordisk Investigational Site

    Marshall, Texas 75670
    United States

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  • Novo Nordisk Investigational Site

    Mesquite, Texas 75149
    United States

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  • Novo Nordisk Investigational Site

    North Richland Hills, Texas 76180
    United States

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  • Novo Nordisk Investigational Site

    Plano, Texas 75075
    United States

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  • Novo Nordisk Investigational Site

    Richardson, Texas 75080
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78258
    United States

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  • Novo Nordisk Investigational Site

    Sealy, Texas 77474
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Sugarland, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Victoria, Texas 77901
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waco, Texas 76710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Draper, Utah 84020
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ogden, Utah 84405
    United States

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  • Novo Nordisk Investigational Site

    Salt Lake City, Utah 84107
    United States

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  • Novo Nordisk Investigational Site

    Chesapeake, Virginia 23321
    United States

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  • Novo Nordisk Investigational Site

    Norfolk, Virginia 23510
    United States

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    Olympia, Washington 98502
    United States

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  • Novo Nordisk Investigational Site

    Renton, Washington 98057
    United States

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  • Novo Nordisk Investigational Site

    Richland, Washington 99352
    United States

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  • Novo Nordisk Investigational Site

    Spokane, Washington 99202-1334
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Martinsburg, West Virginia 25401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin 53144
    United States

    Site Not Available

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