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
Slidell, Louisiana 70461
2096
mi
from 98109
Slidell, LA
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Altoona, Pennsylvania 16602
2204
mi
from 98109
Altoona, PA
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Bradenton, Florida 34201
2552
mi
from 98109
Bradenton, FL
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?
mi
from 98109
Buenos Aires,
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Collierville, Tennessee 38017
1886
mi
from 98109
Collierville, TN
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Colorado Springs, Colorado 80910
1070
mi
from 98109
Colorado Springs, CO
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Dallas, Texas 75231
1677
mi
from 98109
Dallas, TX
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Evansville, Indiana 47714
1868
mi
from 98109
Evansville, IN
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Fort Lauderdale, Florida 33316
2719
mi
from 98109
Fort Lauderdale, FL
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Franklin, Ohio 45005
1961
mi
from 98109
Franklin, OH
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Fresno, California 93702
763
mi
from 98109
Fresno, CA
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Gurnee, Illinois 60031
1706
mi
from 98109
Gurnee, IL
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Kingsport, Tennessee 37660
2150
mi
from 98109
Kingsport, TN
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Lexington, Kentucky 40503
2004
mi
from 98109
Lexington, KY
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Los Alamitos, California 90720
981
mi
from 98109
Los Alamitos, CA
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Louisville, Kentucky 40213
1944
mi
from 98109
Louisville, KY
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Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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Michigan City, Indiana 46360
1772
mi
from 98109
Michigan City, IN
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Oklahoma City, Oklahoma 73112
1523
mi
from 98109
Oklahoma City, OK
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Palm Springs, California 92262
1000
mi
from 98109
Palm Springs, CA
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Pembroke Pines, Florida 33026
2719
mi
from 98109
Pembroke Pines, FL
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Philadelphia, Pennsylvania 19104
2371
mi
from 98109
Philadelphia, PA
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Renton, Washington 98057
11
mi
from 98109
Renton, WA
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Saint Charles, Missouri 63303
1702
mi
from 98109
Saint Charles, MO
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San Antonio, Texas 78224
1787
mi
from 98109
San Antonio, TX
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San Diego, California 92111
1065
mi
from 98109
San Diego, CA
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Spokane, Washington 99202
231
mi
from 98109
Spokane, WA
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Tampa, Florida 33612
2522
mi
from 98109
Tampa, FL
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West Jordan, Utah 84088
707
mi
from 98109
West Jordan, UT
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Wilmington, North Carolina 28401
2455
mi
from 98109
Wilmington, NC
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