The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:11/8/2014
Start Date:May 2014
End Date:April 2015
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com

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A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial

This trial is conducted in Africa, Europe and North America. The purpose of the trial is to
investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1
diabetes.


Inclusion Criteria:

- Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial

- Male or female, aged equal to or greater than 18 years at the time of signing
informed consent

- Type 1 diabetes mellitus (as diagnosed clinically) 12 months or longer prior to Visit
1 (i.e. screening)

- Treatment with basal bolus or CSII (continuous subcutaneous insulin infusion, insulin
pump) treatment 6 months or longer prior to Visit 1 (i.e. screening)

- Stable insulin treatment 3 months or longer prior to Visit 1 (i.e. screening), as
judged and documented by the investigator

- HbA1c 7.0-10.0 percent (Diabetes Control and Complications Trial (DCCT)), both
inclusive, by central laboratory analysis (Visit 1, screening) corresponding to 53-86
mmol/mol (International Federation of Clinical Chemistry (IFCC))

Exclusion Criteria:

- Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase
IV (DPPIV) inhibitors

- Use of any medication, which in the investigator's opinion could interfere with the
glycaemic control (e.g. systemic corticosteroids, pramlintide (Symlin®)) or affect
the subject's safety. Premix insulin is not allowed

- Known proliferative retinopathy or maculopathy requiring acute treatment

- Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged
by the investigator

- Uncontrolled/untreated blood pressure at screening (Visit 1) (after resting for 5
minutes) while sitting greater than 160 mmHg for systolic or greater than 100 mmHg
for diastolic (repeated measurement at Visit 2 (prior to performing the trial related
activities) is allowed to exclude white-coat hypertension)

- History of acute or chronic pancreatitis

- Screening (Visit 1) calcitonin value equal to or greater than 50 ng/L
We found this trial at
45
sites
877
mi
from 91732
Butte, MT
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2438
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from 91732
Albany, NY
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922
mi
from 91732
Amarillo, TX
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1922
mi
from 91732
Atlanta, GA
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825
mi
from 91732
Aurora, CO
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1215
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from 91732
Austin, TX
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1215
mi
from 91732
Austin, TX
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Bennington, Vermont 05201
2468
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Bennington, VT
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Billings, Montana 59101
951
mi
from 91732
Billings, MT
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Bristol, Tennessee 37620
2015
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from 91732
Bristol, TN
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Champaign, Illinois 61082
1684
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Champaign, IL
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Chattanooga, Tennessee 37404
1855
mi
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Chattanooga, TN
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Chesterfield, Missouri 63017
1552
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Chesterfield, MO
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Chicago, Illinois 60607
1728
mi
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Chicago, IL
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Chino, California 91710
19
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Chino, CA
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Concord, California 94520
353
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Concord, CA
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Council Bluffs, Iowa 51501
1302
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Council Bluffs, IA
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1220
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from 91732
Dallas, TX
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1220
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from 91732
Dallas, TX
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Durham, North Carolina 27713
2201
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Durham, NC
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Escondido, California 92026
78
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from 91732
Escondido, CA
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Fargo, North Dakota 58103
1413
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from 91732
Fargo, ND
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Federal Way, Washington 98003
941
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from 91732
Federal Way, WA
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Fresno, California 93720
216
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from 91732
Fresno, CA
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807
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from 91732
Golden, CO
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Jamaica, New York 11432
2444
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from 91732
Jamaica, NY
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Lexington, Kentucky 40503
1879
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from 91732
Lexington, KY
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Little Rock, Arkansas 72205
1460
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from 91732
Little Rock, AR
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Maitland, Florida 32751
2183
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Maitland, FL
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Marietta, Georgia 30066
1907
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from 91732
Marietta, GA
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Minneapolis, Minnesota 55416
1505
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Minneapolis, MN
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Morehead City, North Carolina 28557
2335
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from 91732
Morehead City, NC
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564
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from 91732
Murray, UT
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593
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from 91732
Ogden, UT
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345
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from 91732
Phoenix, AZ
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Renton, Washington 98057
952
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from 91732
Renton, WA
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Rockville, Maryland 20852
2275
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from 91732
Rockville, MD
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1918
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from 91732
Roswell, GA
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San Mateo, California 94401
341
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from 91732
San Mateo, CA
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San Ramon, California 94583
338
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San Ramon, CA
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Seattle, Washington 98122
961
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Seattle, WA
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1724
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Skokie, IL
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Staten Island, New York 10301
2428
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Staten Island, NY
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Walnut Creek, California 94598
348
mi
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Walnut Creek, CA
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Wilmington, North Carolina 28401
2275
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Wilmington, NC
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