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

Last updated: March 6, 2019
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Foot Ulcers

Diabetic Gastroparesis

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT01620489
NN2211-3916
2011-002968-24
U1111-1122-3303
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchangedmedication 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 mustbe used in accordance with local metformin labelling or guidelines. Or Monotherapy orany 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 tothe screening visit as confirmed by the investigator are acceptable. Metformin shouldbe used with caution in subjects with moderate renal failure and must be used inaccordance with local metformin labelling or guidelines. Combination of pioglitazoneand 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 andconfirmed 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

Exclusion Criteria:

  • Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by theinvestigator

  • Treatment with antidiabetic medication(s) other than stated in the inclusion criteriain a period of 90 days prior to screening. Previous short-term (below or equal to 7days in total) treatment with rapid-or short-acting insulin in connection withintercurrent 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, acutecoronary event, cerebral stroke/transient ischemic attack (TIA) or other significantcardiovascular 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 pressureabove or equal to 100 mmHg

  • Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretionof 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 skincancer or squamous cell skin cancer)

  • Proliferative retinopathy or maculopathy requiring acute treatment as judged by theinvestigator

Study Design

Total Participants: 279
Study Start date:
June 14, 2012
Estimated Completion Date:
August 20, 2013

Connect with a study center

  • Novo Nordisk Investigational Site

    Brest, 29609
    France

    Site Not Available

  • empty

    Brest Cedex 9, 29240
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    LA ROCHE-sur-YON cedex 9, 85295
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    LA ROCHELLE cedex, 17019
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Pointe À Pitre, 97159
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Strasbourg, 67000
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Bialystok, 15-435
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdansk, 80-546
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Katowice, 40-767
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Krakow, 31-261
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Poznan, 60-569
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Zabrze, 41-800
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Barnaul, 656045
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kazan, 420043
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kursk, 305035
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 123448
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Nizhniy Novgorod, 603126
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Penza, 440026
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 194358
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Samara, 443067
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saratov, 410053
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Volgograd, 400138
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Kharkiv, 61000
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kiev, 04053
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kyiv, 04114
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Vinnitsa, 21010
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Vinnytsia, 21010
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Zaporizhia, 69600
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Zaporozhye, 69600
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Hull, HU3 2RW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Leicester, LE5 4PW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Letchworth, SG6 4UB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    London, SE5 9RT
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Swansea, SA6 6NL
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, California 94520
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Danville, California 94526
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Encino, California 91436
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    La Jolla, California 92037
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Monterey, California 93940
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Diego, California 92111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Ramon, California 94583
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Torrance, California 90502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tustin, California 92780
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ventura, California 93003
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Golden, Colorado 80401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Miami, Florida 33156
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida 33027
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    St. Petersburg, Florida 33711
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Avon, Indiana 46123
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Franklin, Indiana 46131
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Muncie, Indiana 47304
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Slidell, Louisiana 70461-4231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Southfield, Michigan 48034-7661
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashua, New Hampshire 03063
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rosedale, New York 11422
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Staten Island, New York 10301
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mooresville, North Carolina 28117
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Mason, Ohio 45040-6815
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wadsworth, Ohio 44281-9236
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    McMurray, Pennsylvania 15317
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norristown, Pennsylvania 19401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Upper St Clair, Pennsylvania 15241
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee 37404-1192
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Houston, Texas 77054
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lubbock, Texas 79423
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601
    United States

    Site Not Available

  • Novo Nordisk Clinical Trial Call Center

    Olympia, Washington 98502-5010
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin 53209
    United States

    Site Not Available

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