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 Neuropathy

Diabetic Foot Ulcers

Diabetic Gastroparesis

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

    Site Not Available

  • Novo Nordisk Investigational Site

    Hradec Kralove, 50005
    Czechia

    Site Not Available

  • 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

    Site Not Available

  • Novo Nordisk Investigational Site

    Oulu, 90029
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Seinäjoki, 60220
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Freiburg, 79106
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hannover, 30173
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Ludwigshafen, 67059
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Münster, 48155
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Neuwied, 56564
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Oldenburg, 23758
    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

    Hyderabad, Andhra Pradesh 500072
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat 380007
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kochi, Kerala 682041
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Indore, Madhya Pradesh 452010
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra 400010
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Pune, Maharashtra 411001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu 600 013
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkata, 700026
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    New Delhi, 110060
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Haifa, 31096
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Holon, 58100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Petah Tikva, 49202
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Tel Aviv,
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Zerifin, 70300
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Ancona, 60123
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Catanzaro, 88100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Chieti, 66100
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Napoli, 80131
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Verona, 37126
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Amagasaki-shi, Hyogo, 661-0965
    Japan

    Site Not Available

  • 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

    Site Not Available

  • Novo Nordisk Investigational Site

    Kitakyushu-shi, Fukuoka, 806-8501
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kobe-shi, Hyogo, 657-0846
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kochi-shi, Kochi, 780 0952
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kofu, Yamanashi, 400-0027
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kumamoto-shi, Kumamoto, 860 8556
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kure-shi, Hiroshima, 737-0023
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Maebashi-shi, Gunma, 371-8511
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Matsumoto-shi, Nagano,, 399-8701
    Japan

    Site Not Available

  • 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, 950 1197
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Okayama Kita-ku, Okayama, 700-8607
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Okayama-shi, Okayama, 700-0013
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Osaka-shi, Osaka, 545 8586
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Ota-shi, Gunma, 373-8585
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Otsu-shi, Shiga, 520-0804
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Saga-shi, Saga, 840-0801
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Sendai-shi, Miyagi, 980 8574
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Suzaka-shi ,Nagano, 382-0091
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tochigi, 329-0498
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 101-8309
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tsu-shi, Mie, 514 0125
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yokohama-shi, Kanagawa, 232-0024
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yokosuka-shi, Kanagawa, 238-8567
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Riga, LV1004
    Latvia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kaunas, 50009
    Lithuania

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdansk, 80-952
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warszawa, 04-730
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Wroclaw, 50-368
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Kazan, 420073
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 117036
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Novosibirsk, 630048
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Rostov-on-Don, 344013
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 191036
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Samara, 443079
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saratov, 410054
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Ufa, 450106
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Nis, 18 000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Adana, 01130
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Antalya, 07059
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Istanbul, 34093
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Izmir, 35340
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Samsun, 55139
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    İzmir, 35040
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Dnipro, 49023
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Dnipropetrovsk, 49023
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Ivano-Frankivsk, 76018
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kharkiv, 61153
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kiev, 01021
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kyiv, 04114
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Lviv, 79010
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Vinnitsa, 21010
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Vinnytsia, 21010
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Zaporizhzhia, 69063
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90027
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sacramento, California 95821
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ventura, California 93003
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30339
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boise, Idaho 83712
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Idaho Falls, Idaho 83404-7596
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buffalo, New York 14203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sioux Falls, South Dakota 57105
    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

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.