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
Amarillo, Texas 79106
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Amarillo, TX
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Atlanta, Georgia 30318
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Atlanta, GA
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Aurora, Colorado 80010
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Aurora, CO
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Austin, Texas 78731
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Austin, TX
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Baltimore, Maryland 21229
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Baltimore, MD
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Boise, ID
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Boston, Massachusetts 02115
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Boston, MA
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Buffalo, New York 14222
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Buffalo, NY
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Columbus, Ohio 43205
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Columbus, OH
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Dallas, Texas 75231
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Dallas, TX
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Fargo, North Dakota 58122
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Fargo, ND
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Gainesville, Florida 32608
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Gainesville, FL
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Idaho Falls, Idaho 83404
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Idaho Falls, ID
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Jacksonville, Florida 32207
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Jacksonville, FL
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Las Vegas, Nevada 89128
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Las Vegas, NV
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Lexington, Kentucky 40503
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Lexington, KY
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Long Beach, California 90807
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Long Beach, CA
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Los Angeles, California 90027
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Los Angeles, CA
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Mineola, New York 11501
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Mineola, NY
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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Neptune, New Jersey 07753
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Neptune, NJ
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Orlando, Florida 32804
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Orlando, FL
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Phoenix, Arizona 85053
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Pleven,
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Raleigh, North Carolina 27610
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Raleigh, NC
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Sacramento, California 95821
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Sacramento, CA
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Salt Lake City, Utah 84132
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Salt Lake City, UT
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Sioux Falls, South Dakota 57105
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Sioux Falls, SD
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Springfield, Illinois 62702
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Springfield, IL
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Tallahassee, Florida 32308
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Tallahassee, FL
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Tampa, Florida 33612
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Tampa, FL
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Tucson, Arizona 85704
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Tucson, AZ
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Tulsa, Oklahoma 74135
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Tulsa, OK
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Ventura, California 93003
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Ventura, CA
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