- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01620489
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
6 maart 2019 bijgewerkt door: Novo Nordisk A/S
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
279
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Brest, Frankrijk, 29609
- Novo Nordisk INvestigational Site
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LA ROCHE-sur-YON cedex 9, Frankrijk, 85295
- Novo Nordisk INvestigational Site
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LA ROCHELLE cedex, Frankrijk, 17019
- Novo Nordisk INvestigational Site
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Pointe À Pitre, Frankrijk, 97159
- Novo Nordisk INvestigational Site
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Strasbourg, Frankrijk, 67000
- Novo Nordisk INvestigational Site
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Kharkiv, Oekraïne, 61000
- Novo Nordisk INvestigational Site
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Kiev, Oekraïne, 04053
- Novo Nordisk INvestigational Site
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Kyiv, Oekraïne, 04114
- Novo Nordisk INvestigational Site
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Vinnytsia, Oekraïne, 21010
- Novo Nordisk INvestigational Site
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Zaporizhia, Oekraïne, 69600
- Novo Nordisk INvestigational Site
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Bialystok, Polen, 15-435
- Novo Nordisk INvestigational Site
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Bialystok, Polen, 15-381
- Novo Nordisk INvestigational Site
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Gdansk, Polen, 80-546
- Novo Nordisk INvestigational Site
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Katowice, Polen, 40-767
- Novo Nordisk INvestigational Site
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Krakow, Polen, 31-261
- Novo Nordisk INvestigational Site
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Poznan, Polen, 60-569
- Novo Nordisk INvestigational Site
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Poznan, Polen, 60-111
- Novo Nordisk INvestigational Site
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Zabrze, Polen, 41-800
- Novo Nordisk INvestigational Site
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Barnaul, Russische Federatie, 656045
- Novo Nordisk INvestigational Site
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Kazan, Russische Federatie, 420043
- Novo Nordisk INvestigational Site
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Kursk, Russische Federatie, 305035
- Novo Nordisk INvestigational Site
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Moscow, Russische Federatie, 117036
- Novo Nordisk INvestigational Site
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Moscow, Russische Federatie, 123448
- Novo Nordisk INvestigational Site
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Moscow, Russische Federatie, 127411
- Novo Nordisk INvestigational Site
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Nizhniy Novgorod, Russische Federatie, 603126
- Novo Nordisk INvestigational Site
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Penza, Russische Federatie, 440026
- Novo Nordisk INvestigational Site
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Saint-Petersburg, Russische Federatie, 195257
- Novo Nordisk INvestigational Site
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Saint-Petersburg, Russische Federatie, 194358
- Novo Nordisk INvestigational Site
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Saint-Petersburg, Russische Federatie, 199034
- Novo Nordisk INvestigational Site
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Samara, Russische Federatie, 443067
- Novo Nordisk INvestigational Site
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Saratov, Russische Federatie, 410039
- Novo Nordisk INvestigational Site
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Saratov, Russische Federatie, 410053
- Novo Nordisk INvestigational Site
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Saratov, Russische Federatie, 410031
- Novo Nordisk INvestigational Site
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Smolensk, Russische Federatie, 214019
- Novo Nordisk INvestigational Site
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Volgograd, Russische Federatie, 400138
- Novo Nordisk INvestigational Site
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Bristol, Verenigd Koninkrijk, BS10 5NB
- Novo Nordisk INvestigational Site
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Dundee, Verenigd Koninkrijk, DD1 9SY
- Novo Nordisk INvestigational Site
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Edinburgh, Verenigd Koninkrijk, EH4 2XU
- Novo Nordisk INvestigational Site
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Hull, Verenigd Koninkrijk, HU3 2RW
- Novo Nordisk INvestigational Site
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Leicester, Verenigd Koninkrijk, LE5 4PW
- Novo Nordisk INvestigational Site
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Letchworth, Verenigd Koninkrijk, SG6 4UB
- Novo Nordisk INvestigational Site
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London, Verenigd Koninkrijk, E1 2EF
- Novo Nordisk INvestigational Site
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London, Verenigd Koninkrijk, SE5 9RT
- Novo Nordisk INvestigational Site
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Swansea, Verenigd Koninkrijk, SA6 6NL
- Novo Nordisk INvestigational Site
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California
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Concord, California, Verenigde Staten, 94520
- Novo Nordisk INvestigational Site
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La Jolla, California, Verenigde Staten, 92037
- Novo Nordisk INvestigational Site
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Los Angeles, California, Verenigde Staten, 90057
- Novo Nordisk INvestigational Site
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Monterey, California, Verenigde Staten, 93940
- Novo Nordisk INvestigational Site
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San Diego, California, Verenigde Staten, 92111
- Novo Nordisk INvestigational Site
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San Ramon, California, Verenigde Staten, 94583
- Novo Nordisk INvestigational Site
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Torrance, California, Verenigde Staten, 90502
- Novo Nordisk INvestigational Site
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Tustin, California, Verenigde Staten, 92780
- Novo Nordisk INvestigational Site
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Ventura, California, Verenigde Staten, 93003
- Novo Nordisk INvestigational Site
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Colorado
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Golden, Colorado, Verenigde Staten, 80401
- Novo Nordisk INvestigational Site
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Florida
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Boynton Beach, Florida, Verenigde Staten, 33472
- Novo Nordisk INvestigational Site
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Jacksonville, Florida, Verenigde Staten, 32216
- Novo Nordisk INvestigational Site
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Miami, Florida, Verenigde Staten, 33156
- Novo Nordisk INvestigational Site
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Pembroke Pines, Florida, Verenigde Staten, 33027
- Novo Nordisk INvestigational Site
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Plantation, Florida, Verenigde Staten, 33324
- Novo Nordisk INvestigational Site
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Saint Petersburg, Florida, Verenigde Staten, 33711
- Novo Nordisk INvestigational Site
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30303
- Novo Nordisk INvestigational Site
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Roswell, Georgia, Verenigde Staten, 30076
- Novo Nordisk INvestigational Site
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Indiana
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Avon, Indiana, Verenigde Staten, 46123
- Novo Nordisk INvestigational Site
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Franklin, Indiana, Verenigde Staten, 46131
- Novo Nordisk INvestigational Site
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Greenfield, Indiana, Verenigde Staten, 46140
- Novo Nordisk INvestigational Site
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Muncie, Indiana, Verenigde Staten, 47304
- Novo Nordisk INvestigational Site
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Louisiana
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Slidell, Louisiana, Verenigde Staten, 70461-4231
- Novo Nordisk INvestigational Site
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Maryland
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Rockville, Maryland, Verenigde Staten, 20852
- Novo Nordisk INvestigational Site
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Massachusetts
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Springfield, Massachusetts, Verenigde Staten, 01199
- Novo Nordisk INvestigational Site
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Michigan
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Buckley, Michigan, Verenigde Staten, 49620
- Novo Nordisk INvestigational Site
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Southfield, Michigan, Verenigde Staten, 48034-7661
- Novo Nordisk INvestigational Site
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Montana
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Great Falls, Montana, Verenigde Staten, 59405
- Novo Nordisk INvestigational Site
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New Hampshire
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Nashua, New Hampshire, Verenigde Staten, 03063
- Novo Nordisk INvestigational Site
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New York
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Rosedale, New York, Verenigde Staten, 11422
- Novo Nordisk INvestigational Site
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Staten Island, New York, Verenigde Staten, 10301
- Novo Nordisk INvestigational Site
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North Carolina
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Greenville, North Carolina, Verenigde Staten, 27834
- Novo Nordisk INvestigational Site
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Mooresville, North Carolina, Verenigde Staten, 28117
- Novo Nordisk INvestigational Site
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Ohio
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Franklin, Ohio, Verenigde Staten, 45005
- Novo Nordisk INvestigational Site
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Mason, Ohio, Verenigde Staten, 45040-6815
- Novo Nordisk INvestigational Site
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Wadsworth, Ohio, Verenigde Staten, 44281-9236
- Novo Nordisk INvestigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Novo Nordisk INvestigational Site
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Pennsylvania
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McMurray, Pennsylvania, Verenigde Staten, 15317
- Novo Nordisk INvestigational Site
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Norristown, Pennsylvania, Verenigde Staten, 19401
- Novo Nordisk INvestigational Site
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Novo Nordisk INvestigational Site
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Rhode Island
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East Providence, Rhode Island, Verenigde Staten, 02914
- Novo Nordisk INvestigational Site
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37411
- Novo Nordisk INvestigational Site
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Chattanooga, Tennessee, Verenigde Staten, 37404-1192
- Novo Nordisk INvestigational Site
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Kingsport, Tennessee, Verenigde Staten, 37660
- Novo Nordisk INvestigational Site
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Texas
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Amarillo, Texas, Verenigde Staten, 79106
- Novo Nordisk INvestigational Site
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Lubbock, Texas, Verenigde Staten, 79423
- Novo Nordisk INvestigational Site
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Sugar Land, Texas, Verenigde Staten, 77479
- Novo Nordisk INvestigational Site
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Virginia
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Newport News, Virginia, Verenigde Staten, 23606
- Novo Nordisk INvestigational Site
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Richmond, Virginia, Verenigde Staten, 23294
- Novo Nordisk INvestigational Site
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Richmond, Virginia, Verenigde Staten, 23219
- Novo Nordisk INvestigational Site
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Richmond, Virginia, Verenigde Staten, 23298
- Novo Nordisk INvestigational Site
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Winchester, Virginia, Verenigde Staten, 22601
- Novo Nordisk INvestigational Site
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Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53209
- Novo Nordisk INvestigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
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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.
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Experimenteel: Lire 1,8 mg
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)
Tijdsspanne: Week 0, Week 26
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Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.
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Week 0, Week 26
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
Tijdsspanne: At week 26
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Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.
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At week 26
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Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment
Tijdsspanne: At week 26
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Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.
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At week 26
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Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles
Tijdsspanne: Week 0, week 26
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SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26.
A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement.
The change from baseline to week 26 was estimated using the statistical model.
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Week 0, week 26
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Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)
Tijdsspanne: Week 0, week 26
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Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.
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Week 0, week 26
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Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)
Tijdsspanne: Week 0, week 26
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Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2)
after 26 Weeks of treatment based on the statistical model.
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Week 0, week 26
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 juni 2012
Primaire voltooiing (Werkelijk)
20 augustus 2013
Studie voltooiing (Werkelijk)
20 augustus 2013
Studieregistratiedata
Eerst ingediend
13 juni 2012
Eerst ingediend dat voldeed aan de QC-criteria
13 juni 2012
Eerst geplaatst (Schatting)
15 juni 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 maart 2019
Laatste update ingediend die voldeed aan QC-criteria
6 maart 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NN2211-3916
- 2011-002968-24 (EudraCT-nummer)
- U1111-1122-3303 (Andere identificatie: WHO)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Diabetes mellitus, type 2
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Diabetes Foundation, IndiaNational Diabetes Obesity and Cholesterol FoundationWervingDiabetes mellitus type 2 met complicatiesIndië
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SanofiVoltooidDiabetes mellitus type 1 - Diabetes mellitus type 2Hongarije, Russische Federatie, Duitsland, Polen, Japan, Verenigde Staten, Finland
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India Diabetes Research Foundation & Dr. A. Ramachandran...Voltooid
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Daewoong Pharmaceutical Co. LTD.VoltooidT2DM (diabetes mellitus type 2)Korea, republiek van
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Daewoong Pharmaceutical Co. LTD.VoltooidT2DM (diabetes mellitus type 2)Korea, republiek van
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Scripps Whittier Diabetes InstituteSan Diego State UniversityVoltooidDiabetes mellitus type 2 (T2DM)Verenigde Staten
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Novartis PharmaceuticalsVoltooidDiabetes mellitus type 2 (T2DM)Verenigde Staten
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Merck Sharp & Dohme LLCVoltooidDiabetes mellitus type 2 (T2DM)
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AstraZenecaBristol-Myers SquibbVoltooidDiabetes mellitus type 2 (T2DM)Verenigde Staten
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Novartis PharmaceuticalsVoltooidDiabetes mellitus type 2 (T2DM)Japan