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
Escondido, California 92026
1935
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Escondido, CA
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514
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Albany, NY
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432
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Atlanta, GA
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432
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Atlanta, GA
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1062
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Austin, TX
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Baltimore, Maryland 21287
345
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Baltimore, MD
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Bennington, Vermont 05201
547
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Bennington, VT
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Billings, Montana 59101
1344
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Billings, MT
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1537
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Butte, MT
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Chattanooga, Tennessee 37404
362
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Chattanooga, TN
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Chattanooga, Tennessee 37404
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Chattanooga, TN
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Chesterfield, Missouri 63017
413
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Chesterfield, MO
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Council Bluffs, Iowa 51501
679
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Council Bluffs, IA
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911
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Dallas, TX
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911
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Dallas, TX
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1160
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Denver, CO
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1417
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El Paso, TX
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Encino, California 91436
1982
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Encino, CA
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Federal Way, Washington 98003
2006
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Federal Way, WA
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Greensboro, North Carolina 27408
318
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Greensboro, NC
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Greer, South Carolina 29651
350
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Greer, SC
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986
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Hialeah, FL
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Hollywood, Florida 33021
977
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Hollywood, FL
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Huntington Beach, California 92646
1968
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Huntington Beach, CA
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Idaho Falls, Idaho 83404
1506
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Idaho Falls, ID
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Indianapolis, Indiana 46260
167
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Indianapolis, IN
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460
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Iowa City, IA
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Jacksonville, Florida 32216
673
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Jacksonville, FL
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La Mesa, California 91942
1942
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La Mesa, CA
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Lancaster, California 93534
1950
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Lancaster, CA
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Lawrenceville, New Jersey 08648
438
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Lawrenceville, NJ
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Little Rock, Arkansas 72205
624
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Little Rock, AR
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Marietta, Georgia 30066
423
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Marietta, GA
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Memphis, Tennessee 38163
502
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Memphis, TN
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146
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Mentor, OH
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Metarie, Louisiana 70006
795
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Metarie, LA
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Milwaukee, Wisconsin 53209
335
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Milwaukee, WI
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Mineola, New York 11501
496
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Mineola, NY
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Minneapolis, Minnesota 55416
627
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Minneapolis, MN
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Monterey, California 93940
2104
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Monterey, CA
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Morehead City, North Carolina 28557
499
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Morehead City, NC
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Myrtle Beach, South Carolina 29572
487
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Myrtle Beach, SC
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Norfolk, Virginia 23507
421
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Norfolk, VA
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Pittsburgh, Pennsylvania 15224
166
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Pittsburgh, PA
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414
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Roswell, GA
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Round Rock, Texas 78681
1052
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Salt Lake City, Utah 84107
1514
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San Mateo, California 94401
2105
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San Mateo, CA
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San Ramon, California 94583
2084
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San Ramon, CA
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Savannah, Georgia 31404
557
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Savannah, GA
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Spokane, Washington 99204
1779
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Spokane, WA
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St. Charles, Missouri 63303
411
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St. Charles, MO
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St. Peters, Missouri 63376
414
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St. Peters, MO
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Staten Island, New York 10301
472
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Staten Island, NY
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1008
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Sugarland, TX
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Summerville, South Carolina 29485
505
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Syracuse, New York 13210
414
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Syracuse, NY
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829
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Tampa, FL
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678
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Topeka, KS
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Upper Darby, Pennsylvania 19082
410
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Upper Darby, PA
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Walnut Creek, California 94598
2086
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Walnut Creek, CA
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