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
Lawrenceville, Georgia 30046
2188
mi
from 98109
Lawrenceville, GA
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Albany, New York 12208
2351
mi
from 98109
Albany, NY
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Billings, Montana 59101
667
mi
from 98109
Billings, MT
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Birmingham, Alabama 35215
2077
mi
from 98109
Birmingham, AL
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Blackfoot, Idaho 83221
573
mi
from 98109
Blackfoot, ID
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Charlotte, North Carolina 28277
2281
mi
from 98109
Charlotte, NC
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Cincinnati, Ohio 45229
1966
mi
from 98109
Cincinnati, OH
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Columbus, Ohio 43205
2008
mi
from 98109
Columbus, OH
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Curitiba, Parana 80250
?
mi
from 98109
Curitiba,
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Dallas, Texas 75231
1677
mi
from 98109
Dallas, TX
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Edinburg, Texas 78539
1971
mi
from 98109
Edinburg, TX
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Evansville, Indiana 47714
1868
mi
from 98109
Evansville, IN
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Gainesville, Florida 32608
2453
mi
from 98109
Gainesville, FL
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Henderson, Nevada 89052
889
mi
from 98109
Henderson, NV
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Hollywood, Florida 33024
2722
mi
from 98109
Hollywood, FL
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Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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Humble, Texas 77338
1882
mi
from 98109
Humble, TX
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Jacksonville, Florida 32207
2454
mi
from 98109
Jacksonville, FL
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Kalamazoo, Michigan 49009
1812
mi
from 98109
Kalamazoo, MI
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Kinston, North Carolina 28501
2431
mi
from 98109
Kinston, NC
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Lancaster, California 93534
919
mi
from 98109
Lancaster, CA
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Lexington, Kentucky 40503
2004
mi
from 98109
Lexington, KY
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Maitland, Florida 32751
2543
mi
from 98109
Maitland, FL
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McMurray, Pennsylvania 15317
2134
mi
from 98109
McMurray, PA
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Memphis, Tennessee 38119
1876
mi
from 98109
Memphis, TN
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Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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Miami Lakes, Florida 33016
2720
mi
from 98109
Miami Lakes, FL
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Moncks Corner, South Carolina 29461
2402
mi
from 98109
Moncks Corner, SC
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Montgomery, Alabama 36106
2155
mi
from 98109
Montgomery, AL
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Mount Pleasant, South Carolina 29464
2426
mi
from 98109
Mount Pleasant, SC
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Myrtle Beach, South Carolina 29572
2434
mi
from 98109
Myrtle Beach, SC
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Nashville, Tennessee 37203
1971
mi
from 98109
Nashville, TN
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New Orleans, Louisiana 70112
2099
mi
from 98109
New Orleans, LA
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Northridge, California 91325
946
mi
from 98109
Northridge, CA
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Pittsburgh, Pennsylvania 15224
2132
mi
from 98109
Pittsburgh, PA
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Rochester, Michigan 48307
1919
mi
from 98109
Rochester, MI
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Roswell, Georgia 30076
2168
mi
from 98109
Roswell, GA
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Round Rock, Texas 78681
1759
mi
from 98109
Round Rock, TX
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Sacramento, California 95821
626
mi
from 98109
Sacramento, CA
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San Diego, California 92111
1065
mi
from 98109
San Diego, CA
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San Ramon, California 94583
681
mi
from 98109
San Ramon, CA
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Schertz, Texas 78154
1788
mi
from 98109
Schertz, TX
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Spartanburg, South Carolina 29303
2242
mi
from 98109
Spartanburg, SC
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Spokane, Washington 99202
231
mi
from 98109
Spokane, WA
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Statesboro, Georgia 30461
2353
mi
from 98109
Statesboro, GA
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Tampa, Florida 33612
2522
mi
from 98109
Tampa, FL
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Topeka, Kansas 66606
1455
mi
from 98109
Topeka, KS
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Tucson, Arizona 85704
1212
mi
from 98109
Tucson, AZ
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Vista, California 92083
1032
mi
from 98109
Vista, CA
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West Seneca, New York 14224
2115
mi
from 98109
West Seneca, NY
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Wilmington, North Carolina 28401
2455
mi
from 98109
Wilmington, NC
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