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 de marzo de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
279
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Concord, California, Estados Unidos, 94520
- Novo Nordisk Investigational Site
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La Jolla, California, Estados Unidos, 92037
- Novo Nordisk Investigational Site
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Los Angeles, California, Estados Unidos, 90057
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Monterey, California, Estados Unidos, 93940
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San Diego, California, Estados Unidos, 92111
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San Ramon, California, Estados Unidos, 94583
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Torrance, California, Estados Unidos, 90502
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Tustin, California, Estados Unidos, 92780
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Ventura, California, Estados Unidos, 93003
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Colorado
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Golden, Colorado, Estados Unidos, 80401
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Florida
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Boynton Beach, Florida, Estados Unidos, 33472
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Jacksonville, Florida, Estados Unidos, 32216
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Miami, Florida, Estados Unidos, 33156
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Pembroke Pines, Florida, Estados Unidos, 33027
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Plantation, Florida, Estados Unidos, 33324
- Novo Nordisk Investigational Site
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Saint Petersburg, Florida, Estados Unidos, 33711
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Georgia
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Atlanta, Georgia, Estados Unidos, 30303
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Roswell, Georgia, Estados Unidos, 30076
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Indiana
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Avon, Indiana, Estados Unidos, 46123
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Franklin, Indiana, Estados Unidos, 46131
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Greenfield, Indiana, Estados Unidos, 46140
- Novo Nordisk Investigational Site
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Muncie, Indiana, Estados Unidos, 47304
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Louisiana
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Slidell, Louisiana, Estados Unidos, 70461-4231
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Maryland
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Rockville, Maryland, Estados Unidos, 20852
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01199
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Michigan
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Buckley, Michigan, Estados Unidos, 49620
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Southfield, Michigan, Estados Unidos, 48034-7661
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Montana
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Great Falls, Montana, Estados Unidos, 59405
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New Hampshire
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Nashua, New Hampshire, Estados Unidos, 03063
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New York
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Rosedale, New York, Estados Unidos, 11422
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Staten Island, New York, Estados Unidos, 10301
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North Carolina
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Greenville, North Carolina, Estados Unidos, 27834
- Novo Nordisk Investigational Site
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Mooresville, North Carolina, Estados Unidos, 28117
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Ohio
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Franklin, Ohio, Estados Unidos, 45005
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Mason, Ohio, Estados Unidos, 45040-6815
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Wadsworth, Ohio, Estados Unidos, 44281-9236
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
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Pennsylvania
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McMurray, Pennsylvania, Estados Unidos, 15317
- Novo Nordisk Investigational Site
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Norristown, Pennsylvania, Estados Unidos, 19401
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Philadelphia, Pennsylvania, Estados Unidos, 19107
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Rhode Island
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East Providence, Rhode Island, Estados Unidos, 02914
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37411
- Novo Nordisk Investigational Site
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Chattanooga, Tennessee, Estados Unidos, 37404-1192
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Kingsport, Tennessee, Estados Unidos, 37660
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Texas
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Amarillo, Texas, Estados Unidos, 79106
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Lubbock, Texas, Estados Unidos, 79423
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Sugar Land, Texas, Estados Unidos, 77479
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Virginia
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Newport News, Virginia, Estados Unidos, 23606
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Richmond, Virginia, Estados Unidos, 23294
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Richmond, Virginia, Estados Unidos, 23219
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Richmond, Virginia, Estados Unidos, 23298
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Winchester, Virginia, Estados Unidos, 22601
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53209
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Barnaul, Federación Rusa, 656045
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Kazan, Federación Rusa, 420043
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Kursk, Federación Rusa, 305035
- Novo Nordisk Investigational Site
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Moscow, Federación Rusa, 117036
- Novo Nordisk Investigational Site
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Moscow, Federación Rusa, 123448
- Novo Nordisk Investigational Site
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Moscow, Federación Rusa, 127411
- Novo Nordisk Investigational Site
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Nizhniy Novgorod, Federación Rusa, 603126
- Novo Nordisk Investigational Site
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Penza, Federación Rusa, 440026
- Novo Nordisk Investigational Site
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Saint-Petersburg, Federación Rusa, 195257
- Novo Nordisk Investigational Site
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Saint-Petersburg, Federación Rusa, 194358
- Novo Nordisk Investigational Site
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Saint-Petersburg, Federación Rusa, 199034
- Novo Nordisk Investigational Site
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Samara, Federación Rusa, 443067
- Novo Nordisk Investigational Site
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Saratov, Federación Rusa, 410039
- Novo Nordisk Investigational Site
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Saratov, Federación Rusa, 410053
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Saratov, Federación Rusa, 410031
- Novo Nordisk Investigational Site
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Smolensk, Federación Rusa, 214019
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Volgograd, Federación Rusa, 400138
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Brest, Francia, 29609
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LA ROCHE-sur-YON cedex 9, Francia, 85295
- Novo Nordisk Investigational Site
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LA ROCHELLE cedex, Francia, 17019
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Pointe À Pitre, Francia, 97159
- Novo Nordisk Investigational Site
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Strasbourg, Francia, 67000
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Bialystok, Polonia, 15-435
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Bialystok, Polonia, 15-381
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Gdansk, Polonia, 80-546
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Katowice, Polonia, 40-767
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Krakow, Polonia, 31-261
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Poznan, Polonia, 60-569
- Novo Nordisk Investigational Site
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Poznan, Polonia, 60-111
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Zabrze, Polonia, 41-800
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Bristol, Reino Unido, BS10 5NB
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Dundee, Reino Unido, DD1 9SY
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Edinburgh, Reino Unido, EH4 2XU
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Hull, Reino Unido, HU3 2RW
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Leicester, Reino Unido, LE5 4PW
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Letchworth, Reino Unido, SG6 4UB
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London, Reino Unido, E1 2EF
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London, Reino Unido, SE5 9RT
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Swansea, Reino Unido, SA6 6NL
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Kharkiv, Ucrania, 61000
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Kiev, Ucrania, 04053
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Kyiv, Ucrania, 04114
- Novo Nordisk Investigational Site
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Vinnytsia, Ucrania, 21010
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Zaporizhia, Ucrania, 69600
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: 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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Experimental: Lira 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de junio de 2012
Finalización primaria (Actual)
20 de agosto de 2013
Finalización del estudio (Actual)
20 de agosto de 2013
Fechas de registro del estudio
Enviado por primera vez
13 de junio de 2012
Primero enviado que cumplió con los criterios de control de calidad
13 de junio de 2012
Publicado por primera vez (Estimar)
15 de junio de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de marzo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
6 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NN2211-3916
- 2011-002968-24 (Número EudraCT)
- U1111-1122-3303 (Otro identificador: WHO)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .