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
Chapel Hill, North Carolina 27599
353
mi
from 43215
Chapel Hill, NC
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Albany, New York 12208
513
mi
from 43215
Albany, NY
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Amarillo, Texas 79106
1078
mi
from 43215
Amarillo, TX
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Arlington Heights, Illinois 60004
348
mi
from 43215
Arlington Heights, IL
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?
mi
from 43215
Arlon,
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Asheville, North Carolina 28801
302
mi
from 43215
Asheville, NC
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Atlanta, Georgia 30318
436
mi
from 43215
Atlanta, GA
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Austin, Texas 78731
1065
mi
from 43215
Austin, TX
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Boston, Massachusetts 02115
641
mi
from 43215
Boston, MA
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Chattanooga, Tennessee 37404
362
mi
from 43215
Chattanooga, TN
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Encino, California 91436
1983
mi
from 43215
Encino, CA
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Federal Way, Washington 98003
2005
mi
from 43215
Federal Way, WA
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Fresno, California 93702
1988
mi
from 43215
Fresno, CA
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Idaho Falls, Idaho 83404
1506
mi
from 43215
Idaho Falls, ID
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Las Vegas, Nevada 89128
1762
mi
from 43215
Las Vegas, NV
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Lexington, Kentucky 40503
157
mi
from 43215
Lexington, KY
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Mesquite, Texas 75149
903
mi
from 43215
Mesquite, TX
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Minneapolis, Minnesota 55404
624
mi
from 43215
Minneapolis, MN
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Nashua, New Hampshire 03063
629
mi
from 43215
Nashua, NH
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Newark, Delaware 19713
386
mi
from 43215
Newark, DE
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Pittsburgh, Pennsylvania 15224
163
mi
from 43215
Pittsburgh, PA
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Renton, Washington 98057
2001
mi
from 43215
Renton, WA
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Rockville, Maryland 20852
320
mi
from 43215
Rockville, MD
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Roseville, California 95661
2028
mi
from 43215
Roseville, CA
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San Mateo, California 94401
2108
mi
from 43215
San Mateo, CA
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San Ramon, California 94583
2084
mi
from 43215
San Ramon, CA
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Santa Barbara, California 93105
2039
mi
from 43215
Santa Barbara, CA
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Walnut Creek, California 94598
2084
mi
from 43215
Walnut Creek, CA
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