Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

Last updated: May 22, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Retinopathy

Diabetic Macular Edema

Diabetic Vitreous Hemorrhage

Treatment

N/A

Clinical Study ID

NCT02670915
NN1218-4101
2014-002568-33
JapicCTI-163248
U1111-1158-1170
  • Ages 1-17
  • All Genders

Study Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at thetime of signing informed consent and below 18 years at the time of randomisation -Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported bylaboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolusinsulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulinfor at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) belowor equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit

Exclusion

Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiringhospitalisation within the last 90 days prior to the screening visit - Treatment with anymedication for the indication of diabetes or obesity other than stated in the inclusioncriteria in a period of 90 days before screening

Study Design

Total Participants: 834
Study Start date:
May 04, 2016
Estimated Completion Date:
March 03, 2018

Connect with a study center

  • Novo Nordisk Investigational Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Varna, 9010
    Bulgaria

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  • Novo Nordisk Investigational Site

    Hradec Kralove, 50005
    Czechia

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  • Novo Nordisk Investigational Site

    Opava, 746001
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ostrava - Poruba, 70852
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Pardubice, 53203
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha, 10034
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Usti nad Labem, 40113
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Tallinn, 13419
    Estonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Tartu, 51014
    Estonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Espoo, 02740
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    OYS, 90029
    Finland

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  • Novo Nordisk Investigational Site

    Oulu, 90029
    Finland

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  • Novo Nordisk Investigational Site

    Seinäjoki, 60220
    Finland

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  • Novo Nordisk Investigational Site

    Bochum, 44791
    Germany

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  • Novo Nordisk Investigational Site

    Freiburg, 79106
    Germany

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  • Novo Nordisk Investigational Site

    Hannover, 30173
    Germany

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  • Novo Nordisk Investigational Site

    Ludwigshafen, 67059
    Germany

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  • Novo Nordisk Investigational Site

    Münster, 48155
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Neuwied, 56564
    Germany

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  • Novo Nordisk Investigational Site

    Oldenburg, 23758
    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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    St. Ingbert, 66386
    Germany

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  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh 500003
    India

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    Ahmedabad, Gujarat 380007
    India

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    Kochi, Kerala 682041
    India

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  • Novo Nordisk Investigational Site

    Indore, Madhya Pradesh 452010
    India

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    Mumbai, Maharashtra 400010
    India

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    Pune, Maharashtra 411001
    India

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    Chennai, Tamil Nadu 600 013
    India

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    Kolkata, 700026
    India

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    New Delhi, 110060
    India

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  • Novo Nordisk Investigational Site

    Beer Sheva, 84101
    Israel

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    Haifa, 31096
    Israel

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    Holon, 58100
    Israel

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    Petah Tikva, 49202
    Israel

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    Tel Aviv,
    Israel

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    Zerifin, 70300
    Israel

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    Ancona, 60123
    Italy

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    Catanzaro, 88100
    Italy

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  • Novo Nordisk Investigational Site

    Chieti, 66100
    Italy

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    Napoli, 80131
    Italy

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  • Novo Nordisk Investigational Site

    Verona, 37126
    Italy

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  • Novo Nordisk Investigational Site

    Amagasaki-shi, Hyogo, 661-0965
    Japan

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  • Novo Nordisk Investigational Site

    Chuo-shi, Yamanashi, 409 3898
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Fukuoka, 830-0011
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Hiroshima-shi, Hiroshima, 734-8530
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Iruma-gun, Saitama, 350 0495
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kitakyushu,Fukuoka, 8078556
    Japan

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  • Novo Nordisk Investigational Site

    Kitakyushu-shi, Fukuoka, 806-8501
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kobe-shi, Hyogo, 657-0846
    Japan

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  • Novo Nordisk Investigational Site

    Kochi-shi, Kochi, 780 0952
    Japan

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  • Novo Nordisk Investigational Site

    Kofu, Yamanashi, 400-0027
    Japan

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  • Novo Nordisk Investigational Site

    Kumamoto-shi, Kumamoto, 860 8556
    Japan

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  • Novo Nordisk Investigational Site

    Kure-shi, Hiroshima, 737-0023
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kyoto, 602-8566
    Japan

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  • Novo Nordisk Investigational Site

    Maebashi-shi, Gunma, 371-8511
    Japan

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  • Novo Nordisk Investigational Site

    Matsumoto-shi, Nagano,, 399-8701
    Japan

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  • Novo Nordisk Investigational Site

    Matsuyama-shi, Ehime, 790-8524
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Musashino-shi, Tokyo, 180 0023
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Niigata-shi, Niigata, 951 8520
    Japan

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  • Novo Nordisk Investigational Site

    Okayama Kita-ku, Okayama, 700-8607
    Japan

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  • Novo Nordisk Investigational Site

    Okayama-shi, Okayama, 701-1192
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Osaka-shi, Osaka, 545 8586
    Japan

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  • Novo Nordisk Investigational Site

    Ota-shi, Gunma, 373-8585
    Japan

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  • Novo Nordisk Investigational Site

    Otsu-shi, Shiga, 520-0804
    Japan

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  • Novo Nordisk Investigational Site

    Saga-shi, Saga, 840-0801
    Japan

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  • Novo Nordisk Investigational Site

    Sendai-shi, Miyagi, 980 8574
    Japan

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    Suzaka-shi ,Nagano, 382-0091
    Japan

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    Tochigi, 329-0498
    Japan

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    Tokyo, 101-8309
    Japan

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  • Novo Nordisk Investigational Site

    Tsu-shi, Mie, 514 0125
    Japan

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  • Novo Nordisk Investigational Site

    Yokohama-shi, Kanagawa, 232-0024
    Japan

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  • Novo Nordisk Investigational Site

    Yokosuka-shi, Kanagawa, 238-8567
    Japan

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  • Novo Nordisk Investigational Site

    Riga, LV1004
    Latvia

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    Kaunas, 50009
    Lithuania

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    Gdansk, 80-952
    Poland

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    Warszawa, 04-736
    Poland

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    Wroclaw, 50-368
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    San Juan, 00927
    Puerto Rico

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    Kazan, 420073
    Russian Federation

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    Moscow, 117036
    Russian Federation

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  • Novo Nordisk Investigational Site

    Novosibirsk, 630048
    Russian Federation

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    Rostov-on-Don, 344013
    Russian Federation

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  • Novo Nordisk Investigational Site

    Saint-Petersburg, 191036
    Russian Federation

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    Samara, 443079
    Russian Federation

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  • Novo Nordisk Investigational Site

    Saratov, 410054
    Russian Federation

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  • Novo Nordisk Investigational Site

    Tomsk, 634050
    Russian Federation

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  • Novo Nordisk Investigational Site

    Ufa, 450106
    Russian Federation

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    Belgrade, 11000
    Serbia

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  • Novo Nordisk Investigational Site

    Nis, 18 000
    Serbia

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    Novi Sad, 21000
    Serbia

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  • Novo Nordisk Investigational Site

    Adana, 01130
    Turkey

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    Antalya, 07059
    Turkey

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    Istanbul, 34093
    Turkey

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    Izmir, 35340
    Turkey

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    Samsun, 55139
    Turkey

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    İzmir, 35040
    Turkey

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    Dnipro, 49023
    Ukraine

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    Dnipropetrovsk, 49023
    Ukraine

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    Ivano-Frankivsk, 76018
    Ukraine

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  • Novo Nordisk Investigational Site

    Kharkiv, 61093
    Ukraine

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    Kiev, 01021
    Ukraine

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    Kyiv, 04114
    Ukraine

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    Lviv, 79010
    Ukraine

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  • Novo Nordisk Investigational Site

    Vinnitsa, 21010
    Ukraine

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    Vinnytsia, 21010
    Ukraine

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    Zaporizhzhia, 69063
    Ukraine

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  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85053
    United States

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  • Novo Nordisk Investigational Site

    Tucson, Arizona 85724
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  • Novo Nordisk Investigational Site

    Long Beach, California 90806
    United States

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    Los Angeles, California 90027
    United States

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  • Novo Nordisk Investigational Site

    Sacramento, California 95821
    United States

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  • Novo Nordisk Investigational Site

    Ventura, California 93003
    United States

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  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

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  • Novo Nordisk Investigational Site

    Gainesville, Florida 32608
    United States

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  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32207
    United States

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  • Novo Nordisk Investigational Site

    Orlando, Florida 32806
    United States

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  • Novo Nordisk Investigational Site

    Tallahassee, Florida 32308
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  • Novo Nordisk Investigational Site

    Tampa, Florida 33612
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  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30339
    United States

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  • Novo Nordisk Investigational Site

    Boise, Idaho 83712
    United States

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  • Novo Nordisk Investigational Site

    Idaho Falls, Idaho 83404-7596
    United States

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  • Novo Nordisk Investigational Site

    Springfield, Illinois 62702
    United States

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  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

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  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21229
    United States

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  • Novo Nordisk Investigational Site

    Boston, Massachusetts 02215
    United States

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  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota 55455
    United States

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  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89128
    United States

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  • Novo Nordisk Investigational Site

    Neptune, New Jersey 07753
    United States

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  • Novo Nordisk Investigational Site

    Neptune City, New Jersey 07753
    United States

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  • Novo Nordisk Investigational Site

    Buffalo, New York 14203
    United States

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  • Novo Nordisk Investigational Site

    Mineola, New York 11501
    United States

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  • Novo Nordisk Investigational Site

    Raleigh, North Carolina 27610
    United States

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  • Novo Nordisk Investigational Site

    Fargo, North Dakota 58122
    United States

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  • Novo Nordisk Investigational Site

    Columbus, Ohio 43205
    United States

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  • Novo Nordisk Investigational Site

    Tulsa, Oklahoma 74135
    United States

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  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

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  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania 15224
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  • Novo Nordisk Investigational Site

    Sioux Falls, South Dakota 57105
    United States

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  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

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  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

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  • Novo Nordisk Investigational Site

    Dallas, Texas 75235
    United States

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  • Novo Nordisk Investigational Site

    Round Rock, Texas 78681
    United States

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  • Novo Nordisk Investigational Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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