A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

Last updated: July 10, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetic Gastroparesis

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT01959529
EX1250-4080
U1111-1141-7614
JapicCTI-142464
2013-002371-17
  • Ages > 50
  • All Genders

Study Summary

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Type 2 diabetes - Age above or equal to 50 years with predefinedprevious cardiovascular disease(s) or renal disease or age above or equal to 60 years withpredefined cardiovascular risk factors - HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day - One or more oral or injectable antidiabetic agent(s)

Exclusion

Exclusion Criteria: - An acute coronary or cerebrovascular event in the previous 60 days -Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failureNYHA (New York Heart Association) class IV - Current or past (within the last 5 years)malignant neoplasms (except basal cell and squamous cell skin carcinoma)

Study Design

Total Participants: 7637
Study Start date:
October 29, 2013
Estimated Completion Date:
October 16, 2016

Connect with a study center

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    Algiers, 16000
    Algeria

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    Constantine, 25000
    Algeria

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    Oran, 31000
    Algeria

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    Sidi Bel Abbes, 22000
    Algeria

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    Buenos Aires, C1449AAD
    Argentina

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    Caba, C1440AAD
    Argentina

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    Cordoba, 5000
    Argentina

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    Mar del Plata, B7600FZN
    Argentina

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    Rosario, S2000CUD
    Argentina

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    Zarate, B2800DGH
    Argentina

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    Brasília, Distrito Federal 71625-009
    Brazil

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    Aparecida de Goiania, Goias 74935-530
    Brazil

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    Belém, Para 66073-000
    Brazil

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    Mogi das Cruzes, Sao Paulo 08780-090
    Brazil

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    São Paulo, Sao Paulo 01228-200
    Brazil

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    Fortaleza, 60430-350
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    Porto Alegre, 90035-170
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    Edmonton, Alberta T5J 3N4
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    Winnipeg, Manitoba R3E 3P4
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    Chatham, Ontario N7L 1C1
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    Ottawa, Ontario K1K 4L2
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    Sarnia, Ontario N7T 4X3
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    Laval, Quebec H7T 2P5
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    Bjelovar, 43000
    Croatia

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    Osijek, 31 000
    Croatia

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    Slavonski Brod, 35 000
    Croatia

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    Zagreb, 10 000
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    Athens, GR-10552
    Greece

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    Thessaloniki, GR-54642
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    Hyderabad, Andhra Pradesh 500034
    India

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    Hyderbad, Andhra Pradesh 500 012
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    Ahmedabad, Gujarat 380007
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    Gurgaon, Haryana 122001
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    Bangalore, Karnataka 560 017
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    Kozhikode, Kerala 673017
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    Indore, Madhya Pradesh 452010
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    Goa, Maharashtra 403 202
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    Mumbai, Maharashtra 400007
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    Pune, Maharashtra 411040
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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 600031
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    Coimbatore, Tamil Nadu 641018
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    Lucknow, Uttar Pradesh 226014
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    Kolkata, West Bengal 700054
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    Ludhiana, 141001
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    New Delhi, 110001
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    Bari, 70124
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    Bergamo, 24127
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    Catanzaro, 88100
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    Chieti, 66100
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    Chieti Scalo, 66100
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    Milano, 20122
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    Milano (MI), 20132
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    Olbia, 07026
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    Padova, 35143
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    Palermo, 90127
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    Ravenna, 48121
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    Roma, 00133
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    Sesto San Giovanni (MI), 20099
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    Chuo-ku, Tokyo, 103-0002
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    Kanagawa, 235-0045
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    Kumamoto, 862-0976
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    Kumamoto-shi, Kumamoto, 862-0976
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    Kumamoto-shi,Kumamoto, 862 0976
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    Matsumoto-shi, Nagano, 390-8621
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    Miyazaki, 880-0034
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    Miyazaki-shi, 880 0034
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    Miyazaki-shi, Miyazaki, 880-0034
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    Nagano, 390-8621
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    Ota-ku, 144 0035
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    Ota-ku, Tokyo, 1430015
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    Shinjuku-ku, Tokyo, 162-8655
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    Tokyo, 162-8655
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    Yokohama-shi, 235 0045
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    Yokohama-shi, Kanagawa, 235-0045
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    Goyang, 10380
    Korea, Republic of

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    Seoul, 02841
    Korea, Republic of

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    Suwon, 16247
    Korea, Republic of

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    Suwon-si, Gyeonggi-do, 16247
    Korea, Republic of

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    Alor Setar, 05460
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    Serdang, 43000
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    Guadalajara, Jalisco 44600
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    Cuernavaca, Morelos 62250
    Mexico

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    Distrito Federal, México, D.F. 14080
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    Aguascalientes, 20230
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    Chihuahua, 31200
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    San Luis Potosi, 78200
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    Gdansk, 80-546
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    Krakow, 31-455
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    Oswiecim, 32-600
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    Poznan, 60-589
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    Szczecin, 70-506
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    Warszawa, 02-507
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    Zamosc, 22-400
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    Alba Iulia, Alba 510053
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    Baia Mare, Maramures 430222
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    Targu Mures, Mures 540142
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    Ploiesti, Prahova 100163
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    Ekaterinburg, 620102
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    Kemerovo, 650002
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    Kirov, 610014
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    Krasnodar, 350012
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    Moscow, 123423
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    Nizhny Novgorod, 603018
    Russian Federation

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    Rostov-on-Don, 344068
    Russian Federation

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    Saint-Petersburg, 194356
    Russian Federation

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    Saratov, 410031
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    St. Petersburg, 196084
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    Syktyvkar, 167981
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    Tumen, 625023
    Russian Federation

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    Tver, 170036
    Russian Federation

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    Ulianovsk, 432063
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    Volgograd, 400131
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    Yaroslavl, 150010
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    Port Elizabeth, Eastern Cape 6045
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    Johannesburg, Gauteng 2193
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    Pretoria, Gauteng 0001
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    Durban, KwaZulu-Natal 4092
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    Umkomaas, KwaZulu-Natal 4170
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    Middleburg, Mpumalanga 1055
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    Brits, North West 0250
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    Cape Town, Western Cape 7500
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    Bangkok, 10400
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    Wolverhampton, WV10 0QP
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    Birmingham, Alabama 35294
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    Montgomery, Alabama 36109
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    Gilbert, Arizona 85295
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    Glendale, Arizona 85308
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    Goodyear, Arizona 85395
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    Litchfield Park, Arizona 85340
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    Chino, California 91710
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    Chula Vista, California 91910
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    Concord, California 94520
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    Downey, California 90242
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    Duarte, California 91010
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    Encino, California 91436
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    Fountain Valley, California 92708
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    Fresno, California 93720
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    Monterey, California 93940
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    North Hollywood, California 91606
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    Palm Springs, California 92262
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    Poway, California 92064
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    Santa Ana, California 92704
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    Sherman Oaks, California 91403
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    Thousand Oaks, California 91360
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    Colorado Springs, Colorado 80909
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    Denver, Colorado 80220
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    Golden, Colorado 80401
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    Danbury, Connecticut 06810
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    Norwalk, Connecticut 06851
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    Waterbury, Connecticut 06708
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    Boca Raton, Florida 33433
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    Boynton Beach, Florida 33472
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    Bradenton, Florida 34201
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    Brandon, Florida 33511
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    Clearwater, Florida 33756
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    Cooper City, Florida 33024
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    Doral, Florida 33172
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    Fleming Island, Florida 32003
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    Fort Lauderdale, Florida 33316
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    Gainesville, Florida 32610
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    Green Cove Springs, Florida 32043
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    Hialeah, Florida 33012
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    Jacksonville, Florida 32216
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    Miami, Florida 33136
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    Naples, Florida 34119
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    New Port Richey, Florida 34652
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    Orlando, Florida 32806
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    Panama City, Florida 32401
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    Ponte Vedra, Florida 32081
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    Port Charlotte, Florida 33952
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    Port Orange, Florida 32127
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    South Miami, Florida 33143
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    Tampa, Florida 33624
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    Atlanta, Georgia 30339
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    Decatur, Georgia 30033
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    Dunwoody, Georgia 30338
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    Lawrenceville, Georgia 30046
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    Roswell, Georgia 30076
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    Savannah, Georgia 31406
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    Honolulu, Hawaii 96814
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    Idaho Falls, Idaho 83404-7596
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    Addison, Illinois 60101
    United States

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    Champagne, Illinois 61822
    United States

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    Champaign, Illinois 61821
    United States

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    Chicago, Illinois 60616
    United States

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    Crystal Lake, Illinois 60012
    United States

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    Gurnee, Illinois 60031
    United States

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    Hines, Illinois 60141
    United States

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    Springfield, Illinois 62711
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  • Novo Nordisk Investigational Site

    Brownsburg, Indiana 46112
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46254
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Muncie, Indiana 47304
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa 51501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Slidell, Louisiana 70461-4231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangor, Maine 04401
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    College Park, Maryland 20740
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Watertwon, Massachusetts 02472
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Livonia, Michigan 48152
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Troy, Michigan 48098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olive Branch, Mississippi 38654
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Billings, Montana 59101
    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 68198-4120
    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

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hoboken, New Jersey 07030
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albany, New York 12206
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lake Success, New York 11042
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mineola, New York 11501
    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 10029
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Massapequa, New York 11758-1802
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Northport, New York 11768
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rochester, New York 14607
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Roslyn, New York 11576
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Westfield, New York 14787
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Burlington, North Carolina 27215
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Durham, North Carolina 27713
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Whiteville, North Carolina 28472
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Delaware, Ohio 43015
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Franklin, Ohio 45005
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Perrysburg, Ohio 43551
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Portland, Oregon 97239-3098
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hermitage, Pennsylvania 16148
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Smithfield, Pennsylvania 15478
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Tipton, Pennsylvania 16684
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Upper Darby, Pennsylvania 19082
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilkes-Barre, Pennsylvania 18702
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Willkes Barre, Pennsylvania 18711-3713
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Moncks Corner, South Carolina 29461
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Murrells Inlet, South Carolina 29576
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Orangebu, South Carolina 29118
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404-1192
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Johnson City, Tennessee 37604
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee 37938
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington, Texas 76012
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Carrollton, Texas 75010
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Carrolton, Texas 75007
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fort Worth, Texas 76117
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77008
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Humble, Texas 77338
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Hurst, Texas 76054
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Irving, Texas 75039
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lewisville, Texas 75067
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lewsiville, Texas 75067
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Longview, Texas 75605
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lubbock, Texas 79423
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Midland, Texas 79707
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Odessa, Texas 79761
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pearland, Texas 77584
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richardson, Texas 75080
    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 78229
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Splendora, Texas 77372
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugarland, Texas 77478
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Waco, Texas 76710
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah 84102
    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

    Midlothian, Virginia 23114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richland, Washington 99352
    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

    Milwaukee, Wisconsin 53209
    United States

    Site Not Available

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