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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Vestavia Hills, Alabama 35209
496
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Vestavia Hills, AL
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Albany, New York 12208
513
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Anaheim, California 92801
1962
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Arlington, Texas 76012
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Arlington Heights, Illinois 60004
348
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Asheboro, North Carolina 27203
342
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Asheboro, NC
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Austin, Texas 78731
1065
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Avon, Illinois 46123
393
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Beaver, Pennsylvania 15009
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Beaver, PA
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Burgas,
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Chapel Hill, North Carolina 27599
353
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Chesterfield, Missouri 63017
413
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Chesterfield, MO
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Chicago, Illinois 60612
274
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Chicago, IL
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Colorado Springs, Colorado 80910
1161
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Colorado Springs, CO
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Crystal Lake, Illinois 60012
388
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Crystal Lake, IL
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Dallas, Texas 75231
905
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Dallas, TX
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Greenfield, Indiana 46140
146
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Greenfield, IN
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Greensboro, North Carolina 27408
321
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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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Gurnee, Illinois 60031
303
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Gurnee, IL
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Hickory, North Carolina 28602
306
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Hickory, NC
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Huntsville, Alabama 35801
411
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Huntsville, AL
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925
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Hurst, TX
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Indianapolis, Indiana 46260
166
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Lawrenceville, New Jersey 08648
438
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Lexington, Kentucky 40503
157
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Los Angeles, California 90027
1973
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Melbourne, Florida 32901
832
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Metairie, Louisiana 70002
796
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Methuen, Massachusetts 01844
642
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Miami, Florida 33136
992
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Miami, FL
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Muncie, Indiana 47304
125
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Nashua, New Hampshire 03063
629
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Nashville, Tennessee 37203
333
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New Albany, Indiana 47150
189
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North Dartmouth, Massachusetts 02747
640
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Philadelphia, Pennsylvania 19104
414
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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
1513
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San Antonio, Texas 78224
1138
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Simpsonville, South Carolina 29681
363
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Slidell, Louisiana 70461
770
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Smithtown, New York 11787
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Southfield, Michigan 48034
173
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Statesville, North Carolina 28625
311
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Sugar Land, Texas 77479
1009
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Toms River, New Jersey 08755
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Tustin, California 92780
1957
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Ventura, California 93003
2017
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Waltham, Massachusetts 02453
633
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Waterbury, Connecticut 06708
531
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Waterbury, CT
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