LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:5/26/2018
Start Date:March 3, 2017
End Date:May 8, 2018

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LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors

The trial is conducted in Asia, Europe, North America and South America. The aim of the study
is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2
inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes
mellitus.


Inclusion Criteria:

- Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial.

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

- Diagnosed with type 2 diabetes mellitus.

- HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).

- Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including
fixed-dose drug combination) with a stable dose of metformin (1500 mg or more, or
maximum tolerated dose) for at least 90 days prior to the day of screening. All
medications in compliance with current local label.

- Body mass index of 20 kg/m^2 or above.

Exclusion Criteria:

- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using an adequate contraceptive method (adequate
contraceptive measure as required by local regulation or practice).

- History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.

- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less
than 60 mL/min/1.73m^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO)
classification using isotope dilution mass spectrometry (IDMS) for serum creatinine
measured at screening.

- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria within the past 90 days prior to the day of
screening. However, short term insulin treatment for a maximum of 14 days during the
90 days prior to screening is allowed.

- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
carcinoma. Family is defined as a first degree relative.

- History or presence of pancreatitis (acute or chronic).

- Impaired liver function, defined as ALT 2.5 or more times upper normal limit at
screening.

- Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
We found this trial at
51
sites
Wilmington, North Carolina 28401
1135
mi
from
Wilmington, NC
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Albany, New York 12208
1307
mi
from
Albany, NY
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Billings, Montana 59101
780
mi
from
Billings, MT
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Birmingham, Alabama 35215
684
mi
from
Birmingham, AL
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Blackfoot, Idaho 83221
849
mi
from
Blackfoot, ID
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Charlotte, North Carolina 28277
957
mi
from
Charlotte, NC
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Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
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Columbus, Ohio 43205
810
mi
from
Columbus, OH
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Curitiba, Parana 80250
?
mi
from
Curitiba,
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Dallas, Texas 75231
341
mi
from
Dallas, TX
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Edinburg, Texas 78539
791
mi
from
Edinburg, TX
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Evansville, Indiana 47714
561
mi
from
Evansville, IN
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Gainesville, Florida 32608
1049
mi
from
Gainesville, FL
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Henderson, Nevada 89052
957
mi
from
Henderson, NV
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Hollywood, Florida 33024
1312
mi
from
Hollywood, FL
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Houston, Texas 77030
572
mi
from
Houston, TX
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Humble, Texas 77338
555
mi
from
Humble, TX
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Jacksonville, Florida 32207
1058
mi
from
Jacksonville, FL
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Kalamazoo, Michigan 49009
714
mi
from
Kalamazoo, MI
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Kinston, North Carolina 28501
1134
mi
from
Kinston, NC
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Lancaster, California 93534
1149
mi
from
Lancaster, CA
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Lawrenceville, Georgia 30046
816
mi
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Lawrenceville, GA
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Lexington, Kentucky 40503
724
mi
from
Lexington, KY
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Maitland, Florida 32751
1138
mi
from
Maitland, FL
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McMurray, Pennsylvania 15317
966
mi
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McMurray, PA
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Memphis, Tennessee 38119
480
mi
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Memphis, TN
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Miami, Florida 33136
1320
mi
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Miami, FL
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Miami Lakes, Florida 33016
1309
mi
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Miami Lakes, FL
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Moncks Corner, South Carolina 29461
1048
mi
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Moncks Corner, SC
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Montgomery, Alabama 36106
752
mi
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Montgomery, AL
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Mount Pleasant, South Carolina 29464
1067
mi
from
Mount Pleasant, SC
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Myrtle Beach, South Carolina 29572
1096
mi
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Myrtle Beach, SC
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Nashville, Tennessee 37203
618
mi
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Nashville, TN
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New Orleans, Louisiana 70112
697
mi
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New Orleans, LA
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Northridge, California 91325
1179
mi
from
Northridge, CA
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Pittsburgh, Pennsylvania 15224
971
mi
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Pittsburgh, PA
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Rochester, Michigan 48307
844
mi
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Rochester, MI
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Roswell, Georgia 30076
795
mi
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Roswell, GA
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Round Rock, Texas 78681
499
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Round Rock, TX
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Sacramento, California 95821
1283
mi
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Sacramento, CA
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San Diego, California 92111
1142
mi
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San Diego, CA
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San Ramon, California 94583
1315
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San Ramon, CA
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Schertz, Texas 78154
567
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Schertz, TX
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Spartanburg, South Carolina 29303
903
mi
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Spartanburg, SC
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Spokane, Washington 99202
1200
mi
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Spokane, WA
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Statesboro, Georgia 30461
976
mi
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Statesboro, GA
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Tampa, Florida 33612
1112
mi
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Tampa, FL
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Topeka, Kansas 66606
146
mi
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Topeka, KS
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Tucson, Arizona 85704
832
mi
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Tucson, AZ
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Vista, California 92083
1134
mi
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Vista, CA
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West Seneca, New York 14224
1059
mi
from
West Seneca, NY
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