Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:3/21/2019
Start Date:June 14, 2012
End Date:August 20, 2013

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Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial

This trial is conducted in Europe and the United States of America (USA). The aim of this
trial is to investigate the efficacy and safety of liraglutide in subjects with type 2
diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin
regimen.


Inclusion Criteria:

- Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged
medication and unchanged dose) for 90 days prior to the screening visit including:
Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone.
Metformin should be used with caution in subjects with moderate renal failure and must
be used in accordance with local metformin labelling or guidelines. Or Monotherapy or
any combinations of metformin and/or pioglitazone and/or basal or premix insulin.
Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to
the screening visit as confirmed by the investigator are acceptable. Metformin should
be used with caution in subjects with moderate renal failure and must be used in
accordance with local metformin labelling or guidelines. Combination of pioglitazone
and insulin should be used with caution and according to local labelling or guidelines

- HbA1c 7-10% (both inclusive)

- Moderate renal impairment diagnosed more than 90 days prior to the screening visit and
confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD
(modification of diet in renal disease) formula at the screening visit

- Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion Criteria:

- Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the
investigator

- Treatment with antidiabetic medication(s) other than stated in the inclusion criteria
in a period of 90 days prior to screening. Previous short-term (below or equal to 7
days in total) treatment with rapid-or short-acting insulin in connection with
intercurrent illness is allowed at the discretion of the investigator

- Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to
2.5 times upper normal limit

- History of chronic pancreatitis or idiopathic acute pancreatitis

- Within the past 180 days any of the following: Episode of unstable angina, acute
coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant
cardiovascular event (including e.g. arrhythmias or conduction delays on ECG
(electrocardiogram))

- Heart failure defined as New York Heart Association (NYHA) class IV

- A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure
above or equal to 100 mmHg

- Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion
of the investigator

- Use of immunosuppressive treatment within 90 days prior to screening

- Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin
cancer or squamous cell skin cancer)

- Proliferative retinopathy or maculopathy requiring acute treatment as judged by the
investigator
We found this trial at
51
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Muncie, Indiana 47304
1835
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Amarillo, Texas 79106
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Atlanta, Georgia 30318
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Avon, Indiana 46123
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Boynton Beach, Florida 33472
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Brest,
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Buckley, Michigan 49620
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Chattanooga, Tennessee 37404
1855
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Concord, California 94520
353
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East Providence, Rhode Island 02914
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Franklin, Indiana 46131
1844
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Franklin, IN
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Franklin, Ohio 45005
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Golden, Colorado 80401
807
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Great Falls, Montana 59405
990
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Greenfield, Indiana 46140
1813
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Greenfield, IN
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Greenville, North Carolina 27834
2290
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Jacksonville, Florida 32207
2131
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Kingsport, Tennessee 37660
1994
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La Jolla, California 92037
95
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Los Angeles, California 90027
16
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Lubbock, Texas 79423
927
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1890
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Mason, OH
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McMurray, Pennsylvania 15317
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Miami, Florida 33136
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Milwaukee, Wisconsin 53209
1729
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Monterey, California 93940
279
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Mooresville, North Carolina 28117
2099
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Nashua, New Hampshire 03063
2556
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Newport News, Virginia 23606
2328
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Norristown, Pennsylvania 19401
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Oklahoma City, Oklahoma 73112
1165
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Pembroke Pines, Florida 33026
2314
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Philadelphia, Pennsylvania 19104
2373
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Plantation, Florida 33324
2308
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Richmond, Virginia 23219
2267
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Rockville, Maryland 20852
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Rosedale, New York 11422
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Roswell, Georgia 30076
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Saint Petersburg, Florida 33713
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San Diego, California 92111
106
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San Ramon, California 94583
338
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Slidell, Louisiana 70461
1666
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Southfield, Michigan 48034
1958
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Springfield, Massachusetts 01107
2501
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Staten Island, New York 10301
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Sugar Land, Texas 77479
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Torrance, California 90502
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Tustin, California 92780
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Ventura, California 93003
70
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Wadsworth, Ohio 44281
2029
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Winchester, Virginia 22601
2219
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