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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:1 - 17
Updated:4/6/2019
Start Date:May 4, 2016
End Date:March 3, 2018

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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.


Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at the
time 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 by
laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus
insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin
for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below
or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit
Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiring
hospitalisation within the last 90 days prior to the screening visit - 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 screening
We found this trial at
36
sites
Salt Lake City, Utah 84132
701
mi
from 98109
Salt Lake City, UT
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Amarillo, Texas 79106
1358
mi
from 98109
Amarillo, TX
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Atlanta, Georgia 30318
2179
mi
from 98109
Atlanta, GA
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Aurora, Colorado 80010
1026
mi
from 98109
Aurora, CO
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Austin, Texas 78731
1770
mi
from 98109
Austin, TX
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Baltimore, Maryland 21229
2325
mi
from 98109
Baltimore, MD
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409
mi
from 98109
Boise, ID
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Boston, Massachusetts 02115
2484
mi
from 98109
Boston, MA
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Buffalo, New York 14222
2110
mi
from 98109
Buffalo, NY
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Columbus, Ohio 43205
2008
mi
from 98109
Columbus, OH
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Dallas, Texas 75231
1677
mi
from 98109
Dallas, TX
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Fargo, North Dakota 58122
1194
mi
from 98109
Fargo, ND
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Gainesville, Florida 32608
2453
mi
from 98109
Gainesville, FL
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Idaho Falls, Idaho 83404
577
mi
from 98109
Idaho Falls, ID
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Jacksonville, Florida 32207
2454
mi
from 98109
Jacksonville, FL
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Las Vegas, Nevada 89128
868
mi
from 98109
Las Vegas, NV
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Lexington, Kentucky 40503
2004
mi
from 98109
Lexington, KY
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Long Beach, California 90807
977
mi
from 98109
Long Beach, CA
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Los Angeles, California 90027
956
mi
from 98109
Los Angeles, CA
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Mineola, New York 11501
2417
mi
from 98109
Mineola, NY
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Minneapolis, Minnesota 55404
1392
mi
from 98109
Minneapolis, MN
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Neptune, New Jersey 07753
2417
mi
from 98109
Neptune, NJ
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Orlando, Florida 32804
2544
mi
from 98109
Orlando, FL
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Philadelphia, Pennsylvania 19104
2371
mi
from 98109
Philadelphia, PA
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Phoenix, Arizona 85053
1116
mi
from 98109
Phoenix, AZ
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Pittsburgh, Pennsylvania 15224
2132
mi
from 98109
Pittsburgh, PA
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?
mi
from 98109
Pleven,
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Raleigh, North Carolina 27610
2362
mi
from 98109
Raleigh, NC
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Sacramento, California 95821
626
mi
from 98109
Sacramento, CA
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Sioux Falls, South Dakota 57105
1263
mi
from 98109
Sioux Falls, SD
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Springfield, Illinois 62702
1705
mi
from 98109
Springfield, IL
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Tallahassee, Florida 32308
2330
mi
from 98109
Tallahassee, FL
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Tampa, Florida 33612
2522
mi
from 98109
Tampa, FL
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Tucson, Arizona 85704
1212
mi
from 98109
Tucson, AZ
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Tulsa, Oklahoma 74135
1558
mi
from 98109
Tulsa, OK
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Ventura, California 93003
935
mi
from 98109
Ventura, CA
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