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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:September 20, 2013
End Date:November 4, 2014

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A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V - Basal Insulin Switch)

This trial is conducted globally. The aim of the trial is to compare the efficacy and safety
of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes
mellitus.


Inclusion Criteria: - Type 2 diabetes mellitus - HbA1c 7.0-10.0% [53-86 mmol/mol] (both
inclusive) by central laboratory analysis - Current treatment with insulin glargine for at
least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units
and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose
should be within the range of 20-50 units, both inclusive, on the day of screening, but
individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are
acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated
dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40
kg/m^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for
metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except
metformin and insulin glargine) or anticipated change inconcomitant medication, which in
the investigator's opinion could interfere with the glucose metabolism (e.g. systemic
corticosteroids) - Previous and/or current treatment with any insulin regimen other than
basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent
illness includinggestational diabetes is allowed at the discretion of the investigator) -
Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists
(e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine
aminotransferase) above or equal to 2.5 times upper normal range (UNR) - Impaired renal
function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to
1.5 mg/dL) for males and above or equal to 125 micromol/L (1.4 mg/dL) for females, or as
allowed according to local contraindications for metformin - Screening calcitonin above or
equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or
multiple endocrine neoplasia type 2 (MEN2) - History of chronic pancreatitis or idiopathic
acute pancreatitis
We found this trial at
30
sites
Altoona, Pennsylvania 16602
2203
mi
from 91732
Altoona, PA
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Bradenton, Florida 34201
2149
mi
from 91732
Bradenton, FL
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?
mi
from 91732
Buenos Aires,
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Collierville, Tennessee 38017
1609
mi
from 91732
Collierville, TN
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Colorado Springs, Colorado 80910
804
mi
from 91732
Colorado Springs, CO
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Evansville, Indiana 47714
1716
mi
from 91732
Evansville, IN
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Fort Lauderdale, Florida 33316
2317
mi
from 91732
Fort Lauderdale, FL
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Franklin, Ohio 45005
1891
mi
from 91732
Franklin, OH
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Fresno, California 93702
209
mi
from 91732
Fresno, CA
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Gurnee, Illinois 60031
1721
mi
from 91732
Gurnee, IL
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Kingsport, Tennessee 37660
1994
mi
from 91732
Kingsport, TN
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Lexington, Kentucky 40503
1879
mi
from 91732
Lexington, KY
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Los Alamitos, California 90720
18
mi
from 91732
Los Alamitos, CA
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Louisville, Kentucky 40213
1815
mi
from 91732
Louisville, KY
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Miami, Florida 33136
2321
mi
from 91732
Miami, FL
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Michigan City, Indiana 46360
1765
mi
from 91732
Michigan City, IN
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Oklahoma City, Oklahoma 73112
1165
mi
from 91732
Oklahoma City, OK
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Palm Springs, California 92262
85
mi
from 91732
Palm Springs, CA
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Pembroke Pines, Florida 33026
2314
mi
from 91732
Pembroke Pines, FL
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Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
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Renton, Washington 98057
952
mi
from 91732
Renton, WA
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Saint Charles, Missouri 63303
1558
mi
from 91732
Saint Charles, MO
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San Antonio, Texas 78224
1188
mi
from 91732
San Antonio, TX
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San Diego, California 92111
106
mi
from 91732
San Diego, CA
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Slidell, Louisiana 70461
1666
mi
from 91732
Slidell, LA
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Spokane, Washington 99202
939
mi
from 91732
Spokane, WA
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Tampa, Florida 33612
2134
mi
from 91732
Tampa, FL
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West Jordan, Utah 84088
561
mi
from 91732
West Jordan, UT
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Wilmington, North Carolina 28401
2275
mi
from 91732
Wilmington, NC
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