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
Amarillo, Texas 79106
922
mi
from 91732
Amarillo, TX
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Albany, New York 12208
2438
mi
from 91732
Albany, NY
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Arlington Heights, Illinois 60004
1610
mi
from 91732
Arlington Heights, IL
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?
mi
from 91732
Arlon,
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Asheville, North Carolina 28801
2002
mi
from 91732
Asheville, NC
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Atlanta, Georgia 30318
1919
mi
from 91732
Atlanta, GA
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Austin, Texas 78731
1212
mi
from 91732
Austin, TX
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Boston, Massachusetts 02115
2576
mi
from 91732
Boston, MA
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Chapel Hill, North Carolina 27599
2194
mi
from 91732
Chapel Hill, NC
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Chattanooga, Tennessee 37404
1855
mi
from 91732
Chattanooga, TN
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Encino, California 91436
28
mi
from 91732
Encino, CA
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Federal Way, Washington 98003
942
mi
from 91732
Federal Way, WA
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Fresno, California 93702
209
mi
from 91732
Fresno, CA
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Idaho Falls, Idaho 83404
721
mi
from 91732
Idaho Falls, ID
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Las Vegas, Nevada 89128
213
mi
from 91732
Las Vegas, NV
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Lexington, Kentucky 40503
1879
mi
from 91732
Lexington, KY
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Mesquite, Texas 75149
1235
mi
from 91732
Mesquite, TX
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Minneapolis, Minnesota 55404
1509
mi
from 91732
Minneapolis, MN
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Nashua, New Hampshire 03063
2556
mi
from 91732
Nashua, NH
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Newark, Delaware 19713
2345
mi
from 91732
Newark, DE
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Pittsburgh, Pennsylvania 15224
2119
mi
from 91732
Pittsburgh, PA
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Renton, Washington 98057
952
mi
from 91732
Renton, WA
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Rockville, Maryland 20852
2275
mi
from 91732
Rockville, MD
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Roseville, California 95661
369
mi
from 91732
Roseville, CA
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San Mateo, California 94401
342
mi
from 91732
San Mateo, CA
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San Ramon, California 94583
338
mi
from 91732
San Ramon, CA
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Santa Barbara, California 93105
99
mi
from 91732
Santa Barbara, CA
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Walnut Creek, California 94598
354
mi
from 91732
Walnut Creek, CA
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