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
Federal Way, Washington 98003
1403
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Federal Way, WA
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1308
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from
Albany, NY
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803
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Atlanta, GA
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803
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Atlanta, GA
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516
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from
Austin, TX
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Baltimore, Maryland 21287
1149
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from
Baltimore, MD
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Bennington, Vermont 05201
1339
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from
Bennington, VT
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Billings, Montana 59101
780
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from
Billings, MT
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945
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Butte, MT
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Chattanooga, Tennessee 37404
721
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from
Chattanooga, TN
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Chattanooga, Tennessee 37404
721
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Chattanooga, TN
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Chesterfield, Missouri 63017
398
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Chesterfield, MO
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Council Bluffs, Iowa 51501
260
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Council Bluffs, IA
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344
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Dallas, TX
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344
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Dallas, TX
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407
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Denver, CO
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635
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El Paso, TX
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Encino, California 91436
1179
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Encino, CA
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Escondido, California 92026
1127
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Escondido, CA
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Greensboro, North Carolina 27408
999
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Greensboro, NC
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Greer, South Carolina 29651
888
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Greer, SC
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1312
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Hialeah, FL
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Hollywood, Florida 33021
1310
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Hollywood, FL
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Huntington Beach, California 92646
1162
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Huntington Beach, CA
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Idaho Falls, Idaho 83404
839
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Idaho Falls, ID
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Indianapolis, Indiana 46260
643
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Indianapolis, IN
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429
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Iowa City, IA
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Jacksonville, Florida 32216
1061
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Jacksonville, FL
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La Mesa, California 91942
1133
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La Mesa, CA
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Lancaster, California 93534
1149
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Lancaster, CA
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Lawrenceville, New Jersey 08648
1247
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Lawrenceville, NJ
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Little Rock, Arkansas 72205
369
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Little Rock, AR
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Marietta, Georgia 30066
787
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Marietta, GA
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Memphis, Tennessee 38163
470
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Memphis, TN
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915
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Mentor, OH
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Metarie, Louisiana 70006
688
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Metarie, LA
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Milwaukee, Wisconsin 53209
637
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Milwaukee, WI
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Mineola, New York 11501
1305
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Mineola, NY
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Minneapolis, Minnesota 55416
548
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Minneapolis, MN
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Monterey, California 93940
1323
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Monterey, CA
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Morehead City, North Carolina 28557
1189
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Morehead City, NC
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Myrtle Beach, South Carolina 29572
1098
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Myrtle Beach, SC
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Norfolk, Virginia 23507
1180
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Norfolk, VA
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Pittsburgh, Pennsylvania 15224
974
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Pittsburgh, PA
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795
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Roswell, GA
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Round Rock, Texas 78681
499
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Round Rock, TX
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Salt Lake City, Utah 84107
778
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Salt Lake City, UT
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San Mateo, California 94401
1335
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San Mateo, CA
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San Ramon, California 94583
1315
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San Ramon, CA
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Savannah, Georgia 31404
1026
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Savannah, GA
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Spokane, Washington 99204
1202
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Spokane, WA
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St. Charles, Missouri 63303
399
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St. Charles, MO
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St. Peters, Missouri 63376
396
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St. Peters, MO
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Staten Island, New York 10301
1282
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Staten Island, NY
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576
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Sugarland, TX
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Summerville, South Carolina 29485
1044
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Summerville, SC
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Syracuse, New York 13210
1194
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Syracuse, NY
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1114
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Tampa, FL
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145
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Topeka, KS
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Upper Darby, Pennsylvania 19082
1219
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Upper Darby, PA
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Walnut Creek, California 94598
1319
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Walnut Creek, CA
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