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
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Baltimore, Maryland 21287
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Bennington, Vermont 05201
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Billings, Montana 59101
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Chattanooga, Tennessee 37404
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Chesterfield, Missouri 63017
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Council Bluffs, Iowa 51501
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Encino, California 91436
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Escondido, California 92026
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Federal Way, Washington 98003
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Greensboro, North Carolina 27408
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Greer, South Carolina 29651
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Hollywood, Florida 33021
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Huntington Beach, California 92646
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32216
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La Mesa, California 91942
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Lancaster, California 93534
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Lawrenceville, New Jersey 08648
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Marietta, Georgia 30066
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Memphis, Tennessee 38163
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Metarie, Louisiana 70006
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Milwaukee, Wisconsin 53209
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Mineola, New York 11501
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Monterey, California 93940
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Morehead City, North Carolina 28557
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Norfolk, Virginia 23507
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