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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

NCT ID: NCT01620489

Last Updated: 2019-03-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-14

Study Completion Date

2013-08-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lira 1.8 mg

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Interventions

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liraglutide

1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Intervention Type DRUG

placebo

Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Intervention Type DRUG

Eligibility Criteria

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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)

* 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

Exclusion Criteria

* Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Concord, California, United States

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Novo Nordisk Investigational Site

La Jolla, California, United States

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Los Angeles, California, United States

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Monterey, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Torrance, California, United States

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Tustin, California, United States

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Ventura, California, United States

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Golden, Colorado, United States

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Boynton Beach, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Roswell, Georgia, United States

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Avon, Indiana, United States

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Franklin, Indiana, United States

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Greenfield, Indiana, United States

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Muncie, Indiana, United States

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Slidell, Louisiana, United States

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Rockville, Maryland, United States

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Springfield, Massachusetts, United States

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Buckley, Michigan, United States

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Southfield, Michigan, United States

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Great Falls, Montana, United States

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Nashua, New Hampshire, United States

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Rosedale, New York, United States

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Staten Island, New York, United States

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Greenville, North Carolina, United States

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Mooresville, North Carolina, United States

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Franklin, Ohio, United States

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Mason, Ohio, United States

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Wadsworth, Ohio, United States

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Oklahoma City, Oklahoma, United States

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McMurray, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Amarillo, Texas, United States

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Lubbock, Texas, United States

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Sugar Land, Texas, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Winchester, Virginia, United States

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Milwaukee, Wisconsin, United States

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Brest, , France

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La Roche-sur-Yon, , France

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La Rochelle, , France

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Pointe à Pitre, , France

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Strasbourg, , France

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Bialystok, , Poland

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Bialystok, , Poland

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Gdansk, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Zabrze, , Poland

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Barnaul, , Russia

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Kazan', , Russia

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Kursk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Volgograd, , Russia

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhia, , Ukraine

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Bristol, , United Kingdom

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Dundee, , United Kingdom

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Edinburgh, , United Kingdom

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Hull, , United Kingdom

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Leicester, , United Kingdom

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Letchworth Garden City, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Swansea, , United Kingdom

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Countries

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United States France Poland Russia Ukraine United Kingdom

References

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Davies MJ, Bain SC, Atkin SL, Rossing P, Scott D, Shamkhalova MS, Bosch-Traberg H, Syren A, Umpierrez GE. Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Diabetes Care. 2016 Feb;39(2):222-30. doi: 10.2337/dc14-2883. Epub 2015 Dec 17.

Reference Type RESULT
PMID: 26681713 (View on PubMed)

Zobel EH, von Scholten BJ, Goldman B, Persson F, Hansen TW, Rossing P. Pleiotropic effects of liraglutide in patients with type 2 diabetes and moderate renal impairment: Individual effects of treatment. Diabetes Obes Metab. 2019 May;21(5):1261-1265. doi: 10.1111/dom.13638. Epub 2019 Feb 22.

Reference Type RESULT
PMID: 30663196 (View on PubMed)

Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

Reference Type DERIVED
PMID: 39963952 (View on PubMed)

Kim JD, Park CY, Cha BY, Ahn KJ, Kim IJ, Park KS, Lee HW, Min KW, Won JC, Chung MY, Kim JT, Kang JG, Park SW. Comparison of Adherence to Glimepiride/Metformin Sustained Release Once-daily Versus Glimepiride/Metformin Immediate Release BID Fixed-combination Therapy Using the Medication Event Monitoring System in Patients With Type 2 Diabetes. Clin Ther. 2018 May;40(5):752-761.e2. doi: 10.1016/j.clinthera.2018.04.002. Epub 2018 May 3.

Reference Type DERIVED
PMID: 29729957 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-002968-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1122-3303

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-3916

Identifier Type: -

Identifier Source: org_study_id

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