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
Walnut Creek, California 94598
1318
mi
from
Walnut Creek, CA
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Albany, New York 12208
1307
mi
from
Albany, NY
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Amarillo, Texas 79106
283
mi
from
Amarillo, TX
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Arlington Heights, Illinois 60004
465
mi
from
Arlington Heights, IL
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?
mi
from
Arlon,
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Asheville, North Carolina 28801
857
mi
from
Asheville, NC
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Atlanta, Georgia 30318
801
mi
from
Atlanta, GA
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Austin, Texas 78731
517
mi
from
Austin, TX
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Boston, Massachusetts 02115
1442
mi
from
Boston, MA
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Chapel Hill, North Carolina 27599
1043
mi
from
Chapel Hill, NC
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Chattanooga, Tennessee 37404
721
mi
from
Chattanooga, TN
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Dallas, Texas 75231
341
mi
from
Dallas, TX
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Encino, California 91436
1180
mi
from
Encino, CA
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Federal Way, Washington 98003
1402
mi
from
Federal Way, WA
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Fresno, California 93702
1205
mi
from
Fresno, CA
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Idaho Falls, Idaho 83404
839
mi
from
Idaho Falls, ID
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Las Vegas, Nevada 89128
967
mi
from
Las Vegas, NV
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Lexington, Kentucky 40503
724
mi
from
Lexington, KY
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Mesquite, Texas 75149
351
mi
from
Mesquite, TX
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Minneapolis, Minnesota 55404
551
mi
from
Minneapolis, MN
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Nashua, New Hampshire 03063
1425
mi
from
Nashua, NH
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Newark, Delaware 19713
1194
mi
from
Newark, DE
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Pittsburgh, Pennsylvania 15224
971
mi
from
Pittsburgh, PA
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Renton, Washington 98057
1402
mi
from
Renton, WA
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Rockville, Maryland 20852
1122
mi
from
Rockville, MD
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Roseville, California 95661
1269
mi
from
Roseville, CA
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San Mateo, California 94401
1337
mi
from
San Mateo, CA
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San Ramon, California 94583
1315
mi
from
San Ramon, CA
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Santa Barbara, California 93105
1239
mi
from
Santa Barbara, CA
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