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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:5/3/2014
Start Date:November 2013
End Date:May 2015
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com

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The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial

This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety
of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total
trial duration per subject is approximately 58 weeks.


Inclusion Criteria:

- Informed consent obtained

- Type 1 diabetes mellitus for 12 months or longer

- Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump)
treatment for 6 months or longer

- Stable insulin treatment for the last 3 months prior to Screening, as judged and
documented by the investigator

- HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive,
(corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry
(IFCC))

- Ability and willingness to comply with all protocol procedures e.g. correct handling
of trial product, complete trial related questionnaires, diaries, self-monitoring of
plasma glucose, self titration of insulin and attend all scheduled visits

Exclusion Criteria:

- Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase
IV (DPP-4) inhibitors

- Use of any medication, which in the investigator's opinion could interfere with the
glycaemic control 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 above 160 mmHg for systolic or
above 100 mmHg for diastolic

- History of acute or chronic pancreatitis

- Screening calcitonin value equal to or above 50 ng/L

- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine
Neoplasia type 2 (MEN2)

- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin
cancer or squamous cell skin cancer)
We found this trial at
61
sites
Baltimore, Maryland 21287
2329
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Baltimore, MD
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2351
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Albany, NY
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2180
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Atlanta, GA
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2180
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Atlanta, GA
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1772
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Austin, TX
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Bennington, Vermont 05201
2372
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Billings, Montana 59101
667
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Billings, MT
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477
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from 98109
Butte, MT
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Chattanooga, Tennessee 37404
2085
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Chattanooga, TN
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Chattanooga, Tennessee 37404
2085
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from 98109
Chattanooga, TN
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Chesterfield, Missouri 63017
1702
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Chesterfield, MO
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Council Bluffs, Iowa 51501
1370
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Council Bluffs, IA
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1676
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Dallas, TX
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1676
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Dallas, TX
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1023
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Denver, CO
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1379
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El Paso, TX
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Encino, California 91436
952
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Encino, CA
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Escondido, California 92026
1032
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Escondido, CA
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Federal Way, Washington 98003
21
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Federal Way, WA
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Greensboro, North Carolina 27408
2294
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Greensboro, NC
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Greer, South Carolina 29651
2229
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Greer, SC
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2722
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Hialeah, FL
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Hollywood, Florida 33021
2720
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Hollywood, FL
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Huntington Beach, California 92646
992
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Huntington Beach, CA
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Idaho Falls, Idaho 83404
577
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Idaho Falls, ID
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Indianapolis, Indiana 46260
1862
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Indianapolis, IN
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1557
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Iowa City, IA
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Jacksonville, Florida 32216
2458
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Jacksonville, FL
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La Mesa, California 91942
1063
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La Mesa, CA
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Lancaster, California 93534
919
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Lancaster, CA
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Lawrenceville, New Jersey 08648
2381
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Lawrenceville, NJ
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Little Rock, Arkansas 72205
1779
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Little Rock, AR
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Marietta, Georgia 30066
2163
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Marietta, GA
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Memphis, Tennessee 38163
1865
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Memphis, TN
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2032
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Mentor, OH
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Metarie, Louisiana 70006
2090
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Metarie, LA
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Milwaukee, Wisconsin 53209
1683
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Milwaukee, WI
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Mineola, New York 11501
2417
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Mineola, NY
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Minneapolis, Minnesota 55416
1388
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Minneapolis, MN
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Monterey, California 93940
762
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Monterey, CA
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Morehead City, North Carolina 28557
2490
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Morehead City, NC
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Myrtle Beach, South Carolina 29572
2434
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Myrtle Beach, SC
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Norfolk, Virginia 23507
2428
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Norfolk, VA
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Pittsburgh, Pennsylvania 15224
2134
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Pittsburgh, PA
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2168
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Roswell, GA
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Round Rock, Texas 78681
1759
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Salt Lake City, Utah 84107
706
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Salt Lake City, UT
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San Mateo, California 94401
694
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San Mateo, CA
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San Ramon, California 94583
681
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San Ramon, CA
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Savannah, Georgia 31404
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Spokane, Washington 99204
228
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Spokane, WA
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St. Charles, Missouri 63303
1701
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St. Peters, Missouri 63376
1695
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Staten Island, New York 10301
2400
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Staten Island, NY
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1888
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Sugarland, TX
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Summerville, South Carolina 29485
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Syracuse, New York 13210
2233
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Syracuse, NY
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2524
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Tampa, FL
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1453
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Topeka, KS
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Upper Darby, Pennsylvania 19082
2368
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Walnut Creek, California 94598
671
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Walnut Creek, CA
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