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
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Monterey, California 93940
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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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Buckley, Michigan 49620
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Chattanooga, Tennessee 37404
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Concord, California 94520
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East Providence, Rhode Island 02914
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Franklin, Indiana 46131
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Franklin, Ohio 45005
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Golden, Colorado 80401
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Great Falls, Montana 59405
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Greenfield, Indiana 46140
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Greenville, North Carolina 27834
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Jacksonville, Florida 32207
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Kingsport, Tennessee 37660
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La Jolla, California 92037
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Los Angeles, California 90027
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Lubbock, Texas 79423
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McMurray, Pennsylvania 15317
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Miami, Florida 33136
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Milwaukee, Wisconsin 53209
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Mooresville, North Carolina 28117
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Muncie, Indiana 47304
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Nashua, New Hampshire 03063
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Newport News, Virginia 23606
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Norristown, Pennsylvania 19401
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Oklahoma City, Oklahoma 73112
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Pembroke Pines, Florida 33026
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Philadelphia, Pennsylvania 19104
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Plantation, Florida 33324
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Richmond, Virginia 23219
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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 Ramon, California 94583
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Southfield, Michigan 48034
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