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
Gainesville, Florida 32608
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Albany, New York 12208
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Billings, Montana 59101
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Birmingham, Alabama 35215
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Birmingham, AL
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Blackfoot, Idaho 83221
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Blackfoot, ID
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Charlotte, North Carolina 28277
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Charlotte, NC
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Cincinnati, Ohio 45229
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Columbus, Ohio 43205
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Columbus, OH
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Curitiba, Parana 80250
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Curitiba,
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Dallas, Texas 75231
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Edinburg, Texas 78539
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Evansville, Indiana 47714
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Evansville, IN
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Henderson, Nevada 89052
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Henderson, NV
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Hollywood, Florida 33024
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Hollywood, FL
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Houston, Texas 77030
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Houston, TX
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Humble, Texas 77338
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Humble, TX
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Jacksonville, Florida 32207
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Jacksonville, FL
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Kalamazoo, Michigan 49009
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Kalamazoo, MI
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Kinston, North Carolina 28501
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Kinston, NC
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Lancaster, California 93534
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Lancaster, CA
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Lawrenceville, Georgia 30046
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Lawrenceville, GA
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Lexington, Kentucky 40503
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Maitland, Florida 32751
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McMurray, Pennsylvania 15317
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Memphis, Tennessee 38119
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Miami, Florida 33136
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Miami Lakes, Florida 33016
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Moncks Corner, South Carolina 29461
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Montgomery, Alabama 36106
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Mount Pleasant, South Carolina 29464
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Myrtle Beach, South Carolina 29572
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Nashville, Tennessee 37203
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New Orleans, Louisiana 70112
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Northridge, California 91325
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Pittsburgh, Pennsylvania 15224
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Rochester, Michigan 48307
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Roswell, Georgia 30076
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Round Rock, Texas 78681
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Sacramento, California 95821
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San Diego, California 92111
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San Ramon, California 94583
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Schertz, Texas 78154
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Spartanburg, South Carolina 29303
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Spokane, Washington 99202
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Statesboro, Georgia 30461
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Tampa, Florida 33612
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Topeka, Kansas 66606
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Tucson, Arizona 85704
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Vista, California 92083
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West Seneca, New York 14224
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Wilmington, North Carolina 28401
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