Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes

Last updated: January 6, 2022
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetic Macular Edema

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT03268005
NN1218-4113
2016-000878-38
U1111-1180-0636
  • Ages > 18
  • All Genders

Study Summary

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).

Eligibility Criteria

Inclusion

Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signinginformed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior toscreening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longerprior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basalinsulin once or twice daily and bolus insulin analogue taken with meals at least 3 timesdaily. Treatment with premixed insulin or soluble insulin combination is not considered abasal-bolus regimen. - Treated with or without oral antidiabetic drugs including extendedrelease formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory

Exclusion

at screening (Visit 1). Exclusion Criteria: - Any of the following: myocardial infarction,stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as beingin New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheralartery revascularisation known on the day of screening (Visit 1). - Treatment withinjectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). -Anticipated initiation or change in concomitant medications (for more than 14 consecutivedays) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroidhormones, or corticosteroids).

Study Design

Total Participants: 1264
Study Start date:
September 19, 2017
Estimated Completion Date:
January 29, 2019

Connect with a study center

  • Novo Nordisk Investigational Site

    Caba, C1440AAD
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Cordoba, 5000
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Córdoba, 5008
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Kozloduy, 3320
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Razgrad, 7200
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1618
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Edmonton, Alberta T6G 2E1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Victoria, British Columbia V8V 4A1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Barrie, Ontario L4N 7L3
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, Ontario L4K 4M2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Etobicoke, Ontario M9R 4E1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8M 1K7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Thornhill, Ontario L4J 8L7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Thunder Bay, Ontario P7A 4V7
    Canada

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  • Novo Nordisk Investigational Site

    Toronto, Ontario M4G 3E8
    Canada

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  • Novo Nordisk Investigational Site

    Montreal, Quebec H4T 1Z9
    Canada

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  • Novo Nordisk Investigational Site

    Karlovac, 47000
    Croatia

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  • Novo Nordisk Investigational Site

    Osijek, 31 000
    Croatia

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  • Novo Nordisk Investigational Site

    Varazdin, 42 000
    Croatia

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  • Novo Nordisk Investigational Site

    Zagreb, 10 000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Hradec Králové, 500 36
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Plzen, 32600
    Czechia

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  • Novo Nordisk Investigational Site

    Trutnov, 541 01
    Czechia

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    Dresden, 01219
    Germany

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    Essen, 45136
    Germany

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  • Novo Nordisk Investigational Site

    Falkensee, 14612
    Germany

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    Lingen, 49808
    Germany

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  • Novo Nordisk Investigational Site

    Münster, 48145
    Germany

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  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386
    Germany

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  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386
    Germany

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    Schweinfurt, 97421
    Germany

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    St. Ingbert, 66386
    Germany

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    Athens, 115 25
    Greece

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    Ioannina, 45500
    Greece

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    Larissa, GR-41110
    Greece

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    Thessaloniki, GR-54636
    Greece

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    Catanzaro, 88100
    Italy

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    Chieti, 66100
    Italy

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    Chieti Scalo, 66100
    Italy

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    Cittadella (PD), 35013
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Milano (MI), 20132
    Italy

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    Olbia, 07026
    Italy

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    Palermo, 90129
    Italy

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    Bucheon, 14647
    Korea, Republic of

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    Daegu, 42472
    Korea, Republic of

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    Seongnam-si, 463-707
    Korea, Republic of

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    Seoul, 08308
    Korea, Republic of

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    Wonju, 26426
    Korea, Republic of

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    Bialystok, 15-435
    Poland

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    Poznan, 60-192
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    Skorzewo, 60-185
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    Warsaw, 02-793
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    Warszawa, 02-507
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    Wroclaw, 50-381
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    Ponce, 00716
    Puerto Rico

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  • Novo Nordisk Investigational Site

    Baia Mare, Maramures 430222
    Romania

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    Targu Mures, Mures 540142
    Romania

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    Tirgu Mures, Mures 540142
    Romania

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    Timisoara, Timis 300125
    Romania

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    Brasov, 500283
    Romania

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    Bucharest, 13682
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    Arkhangelsk, 163045
    Russian Federation

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    Kazan, 420073
    Russian Federation

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    Moscow, 123448
    Russian Federation

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    Penza, 440026
    Russian Federation

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    Saint Petersburg, 194291
    Russian Federation

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    Saint-Petersburg, 194356
    Russian Federation

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    Tumen, 625023
    Russian Federation

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    Voronezh, 394018
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    Belgrade, 11000
    Serbia

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    Kragujevac, 34000
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    Nis, 18000
    Serbia

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    Novi Sad, 21000
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    Zajecar, 19000
    Serbia

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  • Novo Nordisk Investigational Site

    Kosice, 040 01
    Slovakia

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  • Novo Nordisk Investigational Site

    Kysucke Nove Mesto, 024 01
    Slovakia

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  • Novo Nordisk Investigational Site

    Lubochna, 03491
    Slovakia

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  • Novo Nordisk Investigational Site

    Lucenec, 984 01
    Slovakia

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  • Novo Nordisk Investigational Site

    Zilina, 01001
    Slovakia

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  • Novo Nordisk Investigational Site

    Alcobendas, 28100
    Spain

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    Almería, 04001
    Spain

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    Girona, 17007
    Spain

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  • Novo Nordisk Investigational Site

    La Coruña, 15006
    Spain

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  • Novo Nordisk Investigational Site

    Pozuelo de Alarcon, 28223
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    Sabadell, 08208
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    Sevilla, 41010
    Spain

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  • Novo Nordisk Investigational Site

    Dnipro, 49038
    Ukraine

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    Kharkiv, 61000
    Ukraine

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  • Novo Nordisk Investigational Site

    Kiev, 03049
    Ukraine

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    Kyiv, 03049
    Ukraine

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  • Novo Nordisk Investigational Site

    Lviv, 79010
    Ukraine

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  • Novo Nordisk Investigational Site

    Ternopil, 46002
    Ukraine

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    Vinnitsa, 21010
    Ukraine

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    Vinnytsia, 21010
    Ukraine

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  • Novo Nordisk Investigational Site

    Concord, California 94520
    United States

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    Fresno, California 93720
    United States

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    Fullerton, California 92835
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  • Novo Nordisk Investigational Site

    Lancaster, California 93534
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  • Novo Nordisk Investigational Site

    Norco, California 92860
    United States

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    Sacramento, California 95821
    United States

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    Ventura, California 93003
    United States

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  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
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  • Novo Nordisk Investigational Site

    Denver, Colorado 80246
    United States

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    Golden, Colorado 80401
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    Waterbury, Connecticut 06708
    United States

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  • Novo Nordisk Investigational Site

    Boynton Beach, Florida 33472
    United States

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  • Novo Nordisk Investigational Site

    Bradenton, Florida 34201
    United States

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  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida 33312
    United States

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    Miami, Florida 33174
    United States

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  • Novo Nordisk Investigational Site

    Tampa, Florida 33634
    United States

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  • Novo Nordisk Investigational Site

    Alpharetta, Georgia 30022
    United States

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  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30342
    United States

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  • Novo Nordisk Investigational Site

    Lawrenceville, Georgia 30046
    United States

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    Roswell, Georgia 30076
    United States

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    Honolulu, Hawaii 96814
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    Chicago, Illinois 60611
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    Peoria, Illinois 61603
    United States

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  • Novo Nordisk Investigational Site

    Springfield, Illinois 62711
    United States

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  • Novo Nordisk Investigational Site

    Valparaiso, Indiana 46383
    United States

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  • Novo Nordisk Investigational Site

    Des Moines, Iowa 50314
    United States

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  • Novo Nordisk Investigational Site

    West Des Moines, Iowa 50266
    United States

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  • Novo Nordisk Investigational Site

    Topeka, Kansas 66606
    United States

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  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40502
    United States

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  • Novo Nordisk Investigational Site

    Rockville, Maryland 20852
    United States

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  • Novo Nordisk Investigational Site

    Waltham, Massachusetts 02453
    United States

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  • Novo Nordisk Investigational Site

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Henderson, Nevada 89052-2649
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Northport, New York 11768
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chapel Hills, North Carolina 27517
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73104-5020
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, South Carolina 29605-4254
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

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  • Novo Nordisk Investigational Site

    Beaumont, Texas 77701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75226
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Longview, Texas 75605
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pearland, Texas 77584
    United States

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  • Novo Nordisk Investigational Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Round Rocks, Texas 78681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ogden, Utah 84405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    South Burlington, Vermont 05403
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chesapeake, Virginia 23321
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olympia, Washington 98502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Seattle, Washington 98105
    United States

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  • Novo Nordisk Investigational Site

    Spokane, Washington 99201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Green Bay, Wisconsin 54303
    United States

    Site Not Available

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