A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

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

Phase

3

Condition

Diabetes Prevention

Diabetic Neuropathy

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT03078478
NN1250-4252
U1111-1184-8175
2016-002801-20
  • Ages > 18
  • All Genders

Study Summary

This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.

Eligibility Criteria

Inclusion

Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent. - Subjects fulfilling at least one of the below criteria (For this inclusion criterion the aim is to include minimum 80% of individuals with a previous episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least one of criteria a-d.): - a) Experienced at least one severe hypoglycaemic episode within the last year (according to the ADA definition, April 2013 (An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.). - b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-EPI by central laboratory analysis. - c) Hypoglycaemic symptom unawareness (History of impaired autonomic responses (tremulousness, sweating, palpitations, and hunger) during hypoglycaemia). - d) Treated with insulin for more than 5 years. - e) Episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (equal to or below 70 mg/dL [equal to or below 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening). - Subjects diagnosed (clinically) with type 2 diabetes mellitus. - Treated with basal only insulin (once daily or twice-daily insulin (insulin detemir; insulin glargine 100 U/mL, biosimilar of insulin glargine 100 U/mL or insulin Neutral Protamine Hagedorn)) equal to or above 90 days prior to the day of screening with or without any of the following anti-diabetic drugs with stable doses for equal to or above 90 days prior to screening: - a) Metformin - b) Dipeptidyl peptidase -4 inhibitor - c) Sodium-glucose co-transporter 2 inhibitor - d) Alpha-glucosidase-inhibitors (acarbose) - e) Thiazolidinediones - f) Marketed oral combination products only including the products listed in criteria 5a-5e - HbA1c equal to or below 9.5% (80 mmol/mol) at screening by central laboratory analysis. - BMI equal to or below 45 kg/m^2. Exclusion Criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening

Study Design

Total Participants: 1609
Study Start date:
March 13, 2017
Estimated Completion Date:
March 04, 2019

Connect with a study center

  • Novo Nordisk Investigational Site

    Calgary, Alberta T2H 2G4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Etobicoke, Ontario M9R 4E1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Markham, Ontario L3P 7P2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Oakville, Ontario L6M 1M1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M4G 3E8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Mirabel, Quebec J7J 2K8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Esbjerg, 6700
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hellerup, 2900
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hillerød, 3400
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Odense, 5000
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Århus C, 8000
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Pärnu, 80018
    Estonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Tallinn, 10138
    Estonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Viljandi, 71024
    Estonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Bad Mergentheim, 97980
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, 13597
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Elsterwerda, 04910
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Essen, 45219
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Falkensee, 14612
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Friedrichsthal, 66299
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 22041
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Lingen, 49808
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Ingbert, 66386
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Athens, GR-11527
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Larissa, GR-41110
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Nikaia, GR-18454
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-57001
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Budapest, H-1083
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Debrecen, 4043
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Kaposvár, 7400
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Szeged, H-6725
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Szombathely, H-9700
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamar, 2318
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Hoenefoss, 3515
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Oslo, 0373
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Skedsmokorset, NO-2020
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Trondheim, 7030
    Norway

    Site Not Available

  • Novo Nordisk Investigational Site

    Bialystok, 15-445
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Bytom, 41-902
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdansk, 80-858
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lublin, 20-362
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Szczecin, 70-506
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warsaw, 00-465
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warszawa, 00-465
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Zabrze, 41-800
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Manati, 00674
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Oradea, Bihor 410469
    Romania

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  • Novo Nordisk Investigational Site

    Bucharest, 022441
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Buzau, 120203
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Galati, 800578
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Belgrade, 11080
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Nis, 18000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fountain Hills, Arizona 85268
    United States

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  • Novo Nordisk Investigational Site

    Glendale, Arizona 85306
    United States

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  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85037
    United States

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  • Novo Nordisk Investigational Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buena Park, California 90620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, California 94520
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Downey, California 90242
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Duarte, California 91010
    United States

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  • Novo Nordisk Investigational Site

    Fresno, California 93720
    United States

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    Hawaiian Gardens, California 90716
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    La Jolla, California 92037
    United States

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  • Novo Nordisk Investigational Site

    Lancaster, California 93534
    United States

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  • Novo Nordisk Investigational Site

    Lomita, California 90717
    United States

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    Los Alamitos, California 90720
    United States

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  • Novo Nordisk Investigational Site

    Los Angeles, California 90057
    United States

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  • Novo Nordisk Investigational Site

    Moreno Valley, California 92555
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Northridge, California 91325
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Palm Springs, California 92262
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pomona, California 91766-2007
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Poway, California 92064
    United States

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  • Novo Nordisk Investigational Site

    Riverside, California 92506
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roseville, California 95661
    United States

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  • Novo Nordisk Investigational Site

    Sacramento, California 95821
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Mateo, California 94401
    United States

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  • Novo Nordisk Investigational Site

    San Ramon, California 94583
    United States

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  • Novo Nordisk Investigational Site

    Stanford, California 94305
    United States

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  • Novo Nordisk Investigational Site

    Van Nuys, California 91405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Vista, California 92083
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Hills, California 91304
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cooper City, Florida 33024
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32277
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami, Florida 33175
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orlando, Florida 32825
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Palm Harbor, Florida 34684-3609
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida 33027
    United States

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  • Novo Nordisk Investigational Site

    Port Charlotte, Florida 33952
    United States

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  • Novo Nordisk Investigational Site

    Tampa, Florida 33606
    United States

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  • Novo Nordisk Investigational Site

    Marietta, Georgia 30067
    United States

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  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

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  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

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  • Novo Nordisk Investigational Site

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Peoria, Illinois 61603
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Springfield, Illinois 62711
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wauconda, Illinois 60084
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Evansville, Indiana 47713
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mishawaka, Indiana 46544
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa 51501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Des Moines, Iowa 50314-2610
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Paducah, Kentucky 42001
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richfield, Minnesota 55432
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Elkhorn, Nebraska 68022
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fremont, Nebraska 68025
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico 87109-2134
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albany, New York 12203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Windsor, New York 12553
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New York, New York 10016
    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

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina 28557-4346
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Colombus, Ohio 43213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    McMurray, Pennsylvania 15317
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19114
    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 Investigational Site

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pelzer, South Carolina 29669
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dakota Dunes, South Dakota 57049
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, Tennessee 37620-7352
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington, Texas 76012-4637
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75226
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77024
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Humble, Texas 77338
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kerrville, Texas 78028
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Braunfels, Texas 78130
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plano, Texas 75075
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waco, Texas 76710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Murray, Utah 84123
    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

    Chesapeake, Virginia 23321
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Midlothian, Virginia 23114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norfolk, Virginia 23510-2015
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Virginia Beach, Virginia 23454
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olympia, Washington 98502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spokane, Washington 99201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin 53144
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Allis, Wisconsin 53227
    United States

    Site Not Available

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