A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:November 28, 2011
End Date:October 4, 2012

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A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira)
and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their
pre-trial treatment with metformin throughout the entire trial.


Inclusion Criteria:

- Subjects with type 2 diabetes

- HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)

- Subjects on stable daily doses for at least 90 days prior to trial start of: Basal
insulin (total daily basal insulin dose within the range of 20-40U in combination
with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more
or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max.
approved dose according to local label) or metformin and glinides (equal to or more
than half of the max. approved dose according to local label)

- BMI (Body Mass Index) more than or equal to 27 kg/m^2

Exclusion Criteria:

- Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide,
liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones
within 90 days prior to trial start

- Impaired liver function

- Impaired renal function

- Screening calcitonin equal to or above 50 ng/l

- Subjects with personal or family history of medullary thyroid carcinoma (MTC) or
multiple endocrine neoplasia type 2 (MEN 2)

- Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis
of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the
last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral
artery revascularisation procedures

- Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal
to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)

- Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
according to physician's opinion

- History of chronic pancreatitis or idiopathic acute pancreatitis
We found this trial at
53
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Waltham, Massachusetts 02453
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Albany, New York 12208
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Anaheim, California 92801
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Arlington, Texas 76012
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Arlington Heights, Illinois 60004
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Asheboro, North Carolina 27203
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Austin, Texas 78731
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Avon, Illinois 46123
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Beaver, Pennsylvania 15009
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Chapel Hill, North Carolina 27599
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Chesterfield, Missouri 63017
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Chicago, Illinois 60612
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Colorado Springs, Colorado 80910
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Crystal Lake, Illinois 60012
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Dallas, Texas 75231
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Greenfield, Indiana 46140
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Greensboro, North Carolina 27408
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Greer, South Carolina 29651
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Gurnee, Illinois 60031
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Hickory, North Carolina 28602
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Huntsville, Alabama 35801
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Indianapolis, Indiana 46260
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Lawrenceville, New Jersey 08648
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Lexington, Kentucky 40503
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Los Angeles, California 90027
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Melbourne, Florida 32901
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Metairie, Louisiana 70002
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Methuen, Massachusetts 01844
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Miami, Florida 33136
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Muncie, Indiana 47304
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Nashua, New Hampshire 03063
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Nashville, Tennessee 37203
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New Albany, Indiana 47150
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North Dartmouth, Massachusetts 02747
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Philadelphia, Pennsylvania 19104
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Rockville, Maryland 20852
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Roswell, Georgia 30076
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Saint Charles, Missouri 63303
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Salt Lake City, Utah 84132
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San Antonio, Texas 78224
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Slidell, Louisiana 70461
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Southfield, Michigan 48034
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Statesville, North Carolina 28625
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Sugar Land, Texas 77479
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Vestavia Hills, Alabama 35209
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Waterbury, Connecticut 06708
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