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
sites
Methuen, Massachusetts 01844
1439
mi
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Methuen, MA
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Albany, New York 12208
1307
mi
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Albany, NY
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Anaheim, California 92801
1157
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Anaheim, CA
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Arlington, Texas 76012
347
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Arlington, TX
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Arlington Heights, Illinois 60004
465
mi
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Arlington Heights, IL
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Asheboro, North Carolina 27203
1005
mi
from
Asheboro, NC
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Austin, Texas 78731
517
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Austin, TX
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Avon, Illinois 46123
443
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Avon, IL
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Beaver, Pennsylvania 15009
957
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Beaver, PA
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?
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Burgas,
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Chapel Hill, North Carolina 27599
1043
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Chapel Hill, NC
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Chesterfield, Missouri 63017
398
mi
from
Chesterfield, MO
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Chicago, Illinois 60612
609
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Chicago, IL
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Colorado Springs, Colorado 80910
383
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Colorado Springs, CO
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Crystal Lake, Illinois 60012
421
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Crystal Lake, IL
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Dallas, Texas 75231
341
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Dallas, TX
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Greenfield, Indiana 46140
663
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Greenfield, IN
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Greensboro, North Carolina 27408
1001
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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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Gurnee, Illinois 60031
613
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Gurnee, IL
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Hickory, North Carolina 28602
921
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Hickory, NC
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Huntsville, Alabama 35801
659
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Huntsville, AL
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339
mi
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Hurst, TX
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Indianapolis, Indiana 46260
643
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Indianapolis, IN
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Lawrenceville, New Jersey 08648
1248
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Lawrenceville, NJ
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Lexington, Kentucky 40503
724
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Lexington, KY
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Los Angeles, California 90027
1169
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Los Angeles, CA
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Melbourne, Florida 32901
1198
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Melbourne, FL
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Metairie, Louisiana 70002
691
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Metairie, LA
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Miami, Florida 33136
1320
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Miami, FL
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Muncie, Indiana 47304
688
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Muncie, IN
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Nashua, New Hampshire 03063
1425
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Nashua, NH
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Nashville, Tennessee 37203
618
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Nashville, TN
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New Albany, Indiana 47150
653
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New Albany, IN
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North Dartmouth, Massachusetts 02747
1446
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North Dartmouth, MA
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Philadelphia, Pennsylvania 19104
1223
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Philadelphia, PA
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Rockville, Maryland 20852
1122
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Rockville, MD
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Roswell, Georgia 30076
795
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Roswell, GA
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Saint Charles, Missouri 63303
404
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Saint Charles, MO
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Salt Lake City, Utah 84132
779
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Salt Lake City, UT
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San Antonio, Texas 78224
576
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San Antonio, TX
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Simpsonville, South Carolina 29681
890
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Simpsonville, SC
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Slidell, Louisiana 70461
691
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Slidell, LA
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Smithtown, New York 11787
1328
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Smithtown, NY
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Southfield, Michigan 48034
836
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Southfield, MI
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Statesville, North Carolina 28625
945
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Statesville, NC
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Sugar Land, Texas 77479
575
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Sugar Land, TX
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Toms River, New Jersey 08755
1276
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Toms River, NJ
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Tustin, California 92780
1152
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Tustin, CA
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Ventura, California 93003
1216
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Ventura, CA
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Vestavia Hills, Alabama 35209
686
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Vestavia Hills, AL
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Waltham, Massachusetts 02453
1434
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Waltham, MA
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Waterbury, Connecticut 06708
1337
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Waterbury, CT
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