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

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

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
Kinston, North Carolina 28501
440
mi
from 43215
Kinston, NC
Click here to add this to my saved trials
Albany, New York 12208
513
mi
from 43215
Albany, NY
Click here to add this to my saved trials
Billings, Montana 59101
1344
mi
from 43215
Billings, MT
Click here to add this to my saved trials
Birmingham, Alabama 35215
481
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
Blackfoot, Idaho 83221
1523
mi
from 43215
Blackfoot, ID
Click here to add this to my saved trials
Charlotte, North Carolina 28277
348
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45229
95
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43205
1
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
Curitiba, Parana 80250
?
mi
from 43215
Curitiba,
Click here to add this to my saved trials
Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Edinburg, Texas 78539
1284
mi
from 43215
Edinburg, TX
Click here to add this to my saved trials
Evansville, Indiana 47714
278
mi
from 43215
Evansville, IN
Click here to add this to my saved trials
Gainesville, Florida 32608
716
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
Henderson, Nevada 89052
1755
mi
from 43215
Henderson, NV
Click here to add this to my saved trials
Hollywood, Florida 33024
978
mi
from 43215
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Humble, Texas 77338
974
mi
from 43215
Humble, TX
Click here to add this to my saved trials
Jacksonville, Florida 32207
672
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
Kalamazoo, Michigan 49009
211
mi
from 43215
Kalamazoo, MI
Click here to add this to my saved trials
Lancaster, California 93534
1950
mi
from 43215
Lancaster, CA
Click here to add this to my saved trials
Lawrenceville, Georgia 30046
418
mi
from 43215
Lawrenceville, GA
Click here to add this to my saved trials
Lexington, Kentucky 40503
157
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
Maitland, Florida 32751
788
mi
from 43215
Maitland, FL
Click here to add this to my saved trials
McMurray, Pennsylvania 15317
156
mi
from 43215
McMurray, PA
Click here to add this to my saved trials
Memphis, Tennessee 38119
503
mi
from 43215
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33136
992
mi
from 43215
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33016
983
mi
from 43215
Miami Lakes, FL
Click here to add this to my saved trials
Moncks Corner, South Carolina 29461
496
mi
from 43215
Moncks Corner, SC
Click here to add this to my saved trials
Montgomery, Alabama 36106
555
mi
from 43215
Montgomery, AL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
525
mi
from 43215
Mount Pleasant, SC
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
490
mi
from 43215
Myrtle Beach, SC
Click here to add this to my saved trials
Nashville, Tennessee 37203
333
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70112
797
mi
from 43215
New Orleans, LA
Click here to add this to my saved trials
Northridge, California 91325
1981
mi
from 43215
Northridge, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
163
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Rochester, Michigan 48307
187
mi
from 43215
Rochester, MI
Click here to add this to my saved trials
Roswell, Georgia 30076
414
mi
from 43215
Roswell, GA
Click here to add this to my saved trials
Round Rock, Texas 78681
1052
mi
from 43215
Round Rock, TX
Click here to add this to my saved trials
Sacramento, California 95821
2043
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
San Diego, California 92111
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
San Ramon, California 94583
2084
mi
from 43215
San Ramon, CA
Click here to add this to my saved trials
Schertz, Texas 78154
1122
mi
from 43215
Schertz, TX
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
351
mi
from 43215
Spartanburg, SC
Click here to add this to my saved trials
Spokane, Washington 99202
1776
mi
from 43215
Spokane, WA
Click here to add this to my saved trials
Statesboro, Georgia 30461
523
mi
from 43215
Statesboro, GA
Click here to add this to my saved trials
Tampa, Florida 33612
823
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Topeka, Kansas 66606
676
mi
from 43215
Topeka, KS
Click here to add this to my saved trials
Tucson, Arizona 85704
1638
mi
from 43215
Tucson, AZ
Click here to add this to my saved trials
Vista, California 92083
1942
mi
from 43215
Vista, CA
Click here to add this to my saved trials
West Seneca, New York 14224
295
mi
from 43215
West Seneca, NY
Click here to add this to my saved trials
Wilmington, North Carolina 28401
485
mi
from 43215
Wilmington, NC
Click here to add this to my saved trials