A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:July 26, 2015
End Date:October 5, 2016

Use our guide to learn which trials are right for you!

This trial is conducted globally. The aim of this trial is to compare efficacy and safety of
insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with
metformin in subjects with type 2 diabetes mellitus.


Inclusion Criteria:

- Male or female, age at least 18 years at the time of signing informed consent

- Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening

- HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by
central laboratory analysis

- Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to
screening

- Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least
56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within
the 56 calendar days prior to screening are acceptable, however on the day of
screening total daily dose should be within the range of 20 units-50 units both
inclusive

- Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least
90 calendar days prior to screening

- Body mass index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria in a period of 90 calendar days before screening

- Anticipated initiation or change in concomitant medications in excess of 14 calendar
days known to affect weight or glucose metabolism, such as weight loss/modifying
(e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)

- Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times
upper limit of normal

- Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per
CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)

- Screening calcitonin at least 50 ng/L

- History of pancreatitis (acute or chronic)

- Personal or family history of medullary thyroid carcinoma or multiple endocrine
neoplasia type 2
We found this trial at
48
sites
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
?
mi
from
Altoona, PA
Click here to add this to my saved trials
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Bermuda Dunes, California 92203
?
mi
from
Bermuda Dunes, CA
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
Blackfoot, Idaho 83221
?
mi
from
Blackfoot, ID
Click here to add this to my saved trials
?
mi
from
Caba,
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43205
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Fresno, California 93702
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jackson Heights, New York 11372
?
mi
from
Jackson Heights, NY
Click here to add this to my saved trials
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89128
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lincoln, California 95648
?
mi
from
Lincoln, CA
Click here to add this to my saved trials
Lomita, California 90717
?
mi
from
Lomita, CA
Click here to add this to my saved trials
Los Angeles, California 90027
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Mason, OH
Click here to add this to my saved trials
Metairie, Louisiana 70002
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Midlothian, Virginia 23114
?
mi
from
Midlothian, VA
Click here to add this to my saved trials
Montclair, California 91763
?
mi
from
Montclair, CA
Click here to add this to my saved trials
Murrells Inlet, South Carolina 29576
?
mi
from
Murrells Inlet, SC
Click here to add this to my saved trials
Natchitoches, Louisiana 71457
?
mi
from
Natchitoches, LA
Click here to add this to my saved trials
New Windsor, New York 12553
?
mi
from
New Windsor, NY
Click here to add this to my saved trials
Northridge, California 91325
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plantation, Florida 33324
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Rockville, Maryland 20852
?
mi
from
Rockville, MD
Click here to add this to my saved trials
San Antonio, Texas 78224
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Mateo, California 94401
?
mi
from
San Mateo, CA
Click here to add this to my saved trials
Shelby, North Carolina 28150
?
mi
from
Shelby, NC
Click here to add this to my saved trials
Shreveport, Louisiana 71105
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Skokie, Illinois 60077
?
mi
from
Skokie, IL
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Statesville, North Carolina 28625
?
mi
from
Statesville, NC
Click here to add this to my saved trials
Sugar Land, Texas 77479
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials
Tuscumbia, Alabama 35674
?
mi
from
Tuscumbia, AL
Click here to add this to my saved trials
Ventura, California 93003
?
mi
from
Ventura, CA
Click here to add this to my saved trials
Waltham, Massachusetts 02453
?
mi
from
Waltham, MA
Click here to add this to my saved trials
Waterbury, Connecticut 06708
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
West Seneca, New York 14224
?
mi
from
West Seneca, NY
Click here to add this to my saved trials