Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:July 6, 2016
End Date:July 21, 2017

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This trial is conducted in Europe and the United States of America (USA). The aim of this
trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of
Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.


Inclusion Criteria:

- Male or female, age at least 18 years at the time of signing the informed consent

- Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or
supported by laboratory analysis as per local guidelines) equal or above 1 year prior
to the day of screening

- Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754),
Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a
rapid acting insulin analogue for at least six months prior to screening and willing
to stay on the same pump model throughout the trial (if the model is changed the
change should not exceed 7 consecutive days.)

- HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central
laboratory at screening

- Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening

- Ability and willingness to take at least 3 daily meal-time insulin bolus infusions
every day throughout the trial

Exclusion Criteria:

- Any of the following: myocardial infarction, stroke, hospitalization for unstable
angina or transient ischaemic attack within the past 180 days prior to the day of
screening

- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening

- History of hospitalization for ketoacidosis below or equal to 180 days prior to the
day of screening

- 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

- Any condition which, in the opinion of the Investigator, might jeopardise a Subject's
safety or compliance with the protocol
We found this trial at
29
sites
Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Albany, New York 12208
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Albany, NY
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Amarillo, Texas 79106
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Amarillo, TX
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Arlington Heights, Illinois 60004
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Arlington Heights, IL
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Arlon,
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Asheville, North Carolina 28801
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Asheville, NC
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Atlanta, Georgia 30318
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Atlanta, GA
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Austin, Texas 78731
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Austin, TX
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Boston, Massachusetts 02115
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Boston, MA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Chattanooga, Tennessee 37404
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Chattanooga, TN
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Dallas, Texas 75231
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Dallas, TX
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Encino, California 91436
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Encino, CA
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Federal Way, Washington 98003
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Federal Way, WA
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Fresno, California 93702
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Fresno, CA
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Idaho Falls, Idaho 83404
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Idaho Falls, ID
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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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Mesquite, Texas 75149
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Mesquite, TX
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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Nashua, New Hampshire 03063
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Nashua, NH
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Newark, Delaware 19713
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Newark, DE
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Renton, Washington 98057
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Renton, WA
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Rockville, Maryland 20852
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Rockville, MD
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Roseville, California 95661
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Roseville, CA
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San Mateo, California 94401
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San Mateo, CA
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San Ramon, California 94583
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San Ramon, CA
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Santa Barbara, California 93105
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Santa Barbara, CA
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Walnut Creek, California 94598
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Walnut Creek, CA
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