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
Dallas, Texas 75231
1225
mi
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Dallas, TX
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Albany, New York 12208
2438
mi
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Albany, NY
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Billings, Montana 59101
951
mi
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Billings, MT
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Birmingham, Alabama 35215
1788
mi
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Birmingham, AL
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Blackfoot, Idaho 83221
699
mi
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Blackfoot, ID
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Charlotte, North Carolina 28277
2101
mi
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Charlotte, NC
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Cincinnati, Ohio 45229
1881
mi
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Cincinnati, OH
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Columbus, Ohio 43205
1960
mi
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Columbus, OH
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Curitiba, Parana 80250
?
mi
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Curitiba,
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Edinburg, Texas 78539
1298
mi
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Edinburg, TX
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Evansville, Indiana 47714
1716
mi
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Evansville, IN
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Gainesville, Florida 32608
2104
mi
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Gainesville, FL
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Henderson, Nevada 89052
213
mi
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Henderson, NV
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Hollywood, Florida 33024
2318
mi
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Hollywood, FL
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Houston, Texas 77030
1357
mi
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Houston, TX
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Humble, Texas 77338
1358
mi
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Humble, TX
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Jacksonville, Florida 32207
2131
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Jacksonville, FL
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Kalamazoo, Michigan 49009
1833
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Kalamazoo, MI
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Kinston, North Carolina 28501
2282
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Kinston, NC
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Lancaster, California 93534
43
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Lancaster, CA
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Lawrenceville, Georgia 30046
1939
mi
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Lawrenceville, GA
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Lexington, Kentucky 40503
1879
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Lexington, KY
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Maitland, Florida 32751
2183
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Maitland, FL
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McMurray, Pennsylvania 15317
2114
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McMurray, PA
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Memphis, Tennessee 38119
1598
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Memphis, TN
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Miami, Florida 33136
2321
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Miami, FL
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Miami Lakes, Florida 33016
2311
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Miami Lakes, FL
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Moncks Corner, South Carolina 29461
2174
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Moncks Corner, SC
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Montgomery, Alabama 36106
1833
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Montgomery, AL
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Mount Pleasant, South Carolina 29464
2188
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Mount Pleasant, SC
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Myrtle Beach, South Carolina 29572
2230
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Myrtle Beach, SC
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Nashville, Tennessee 37203
1762
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Nashville, TN
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New Orleans, Louisiana 70112
1655
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New Orleans, LA
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Northridge, California 91325
30
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Northridge, CA
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Pittsburgh, Pennsylvania 15224
2119
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Pittsburgh, PA
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Rochester, Michigan 48307
1964
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Rochester, MI
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Roswell, Georgia 30076
1918
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Roswell, GA
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Round Rock, Texas 78681
1208
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Round Rock, TX
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Sacramento, California 95821
366
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Sacramento, CA
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San Diego, California 92111
106
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San Diego, CA
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San Ramon, California 94583
338
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San Ramon, CA
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Schertz, Texas 78154
1198
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Schertz, TX
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Spartanburg, South Carolina 29303
2043
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Spartanburg, SC
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Spokane, Washington 99202
939
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Spokane, WA
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Statesboro, Georgia 30461
2085
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Statesboro, GA
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Tampa, Florida 33612
2134
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Tampa, FL
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Topeka, Kansas 66606
1282
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Topeka, KS
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Tucson, Arizona 85704
423
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Tucson, AZ
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Vista, California 92083
74
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Vista, CA
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West Seneca, New York 14224
2184
mi
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West Seneca, NY
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Wilmington, North Carolina 28401
2275
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Wilmington, NC
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