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 mars 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
279
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Brest, France, 29609
- Novo Nordisk Investigational Site
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LA ROCHE-sur-YON cedex 9, France, 85295
- Novo Nordisk Investigational Site
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LA ROCHELLE cedex, France, 17019
- Novo Nordisk Investigational Site
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Pointe À Pitre, France, 97159
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Strasbourg, France, 67000
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Barnaul, Fédération Russe, 656045
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Kazan, Fédération Russe, 420043
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Kursk, Fédération Russe, 305035
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Moscow, Fédération Russe, 117036
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Moscow, Fédération Russe, 123448
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Moscow, Fédération Russe, 127411
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Nizhniy Novgorod, Fédération Russe, 603126
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Penza, Fédération Russe, 440026
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Saint-Petersburg, Fédération Russe, 195257
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Saint-Petersburg, Fédération Russe, 194358
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Saint-Petersburg, Fédération Russe, 199034
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Samara, Fédération Russe, 443067
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Saratov, Fédération Russe, 410039
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Saratov, Fédération Russe, 410053
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Saratov, Fédération Russe, 410031
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Smolensk, Fédération Russe, 214019
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Volgograd, Fédération Russe, 400138
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Bialystok, Pologne, 15-435
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Bialystok, Pologne, 15-381
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Gdansk, Pologne, 80-546
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Katowice, Pologne, 40-767
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Krakow, Pologne, 31-261
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Poznan, Pologne, 60-569
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Poznan, Pologne, 60-111
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Zabrze, Pologne, 41-800
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Bristol, Royaume-Uni, BS10 5NB
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Dundee, Royaume-Uni, DD1 9SY
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Edinburgh, Royaume-Uni, EH4 2XU
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Hull, Royaume-Uni, HU3 2RW
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Leicester, Royaume-Uni, LE5 4PW
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Letchworth, Royaume-Uni, SG6 4UB
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London, Royaume-Uni, E1 2EF
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London, Royaume-Uni, SE5 9RT
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Swansea, Royaume-Uni, SA6 6NL
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Kharkiv, Ukraine, 61000
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Kiev, Ukraine, 04053
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Kyiv, Ukraine, 04114
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Vinnytsia, Ukraine, 21010
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Zaporizhia, Ukraine, 69600
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California
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Concord, California, États-Unis, 94520
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La Jolla, California, États-Unis, 92037
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Los Angeles, California, États-Unis, 90057
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Monterey, California, États-Unis, 93940
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San Diego, California, États-Unis, 92111
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San Ramon, California, États-Unis, 94583
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Torrance, California, États-Unis, 90502
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Tustin, California, États-Unis, 92780
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Ventura, California, États-Unis, 93003
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Colorado
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Golden, Colorado, États-Unis, 80401
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Florida
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Boynton Beach, Florida, États-Unis, 33472
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Jacksonville, Florida, États-Unis, 32216
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Miami, Florida, États-Unis, 33156
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Pembroke Pines, Florida, États-Unis, 33027
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Plantation, Florida, États-Unis, 33324
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Saint Petersburg, Florida, États-Unis, 33711
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Georgia
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Atlanta, Georgia, États-Unis, 30303
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Roswell, Georgia, États-Unis, 30076
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Indiana
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Avon, Indiana, États-Unis, 46123
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Franklin, Indiana, États-Unis, 46131
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Greenfield, Indiana, États-Unis, 46140
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Muncie, Indiana, États-Unis, 47304
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Louisiana
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Slidell, Louisiana, États-Unis, 70461-4231
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Maryland
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Rockville, Maryland, États-Unis, 20852
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Massachusetts
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Springfield, Massachusetts, États-Unis, 01199
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Michigan
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Buckley, Michigan, États-Unis, 49620
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Southfield, Michigan, États-Unis, 48034-7661
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Montana
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Great Falls, Montana, États-Unis, 59405
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New Hampshire
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Nashua, New Hampshire, États-Unis, 03063
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New York
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Rosedale, New York, États-Unis, 11422
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Staten Island, New York, États-Unis, 10301
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North Carolina
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Greenville, North Carolina, États-Unis, 27834
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Mooresville, North Carolina, États-Unis, 28117
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Ohio
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Franklin, Ohio, États-Unis, 45005
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Mason, Ohio, États-Unis, 45040-6815
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Wadsworth, Ohio, États-Unis, 44281-9236
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
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Pennsylvania
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McMurray, Pennsylvania, États-Unis, 15317
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Norristown, Pennsylvania, États-Unis, 19401
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Philadelphia, Pennsylvania, États-Unis, 19107
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Rhode Island
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East Providence, Rhode Island, États-Unis, 02914
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37411
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Chattanooga, Tennessee, États-Unis, 37404-1192
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Kingsport, Tennessee, États-Unis, 37660
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Texas
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Amarillo, Texas, États-Unis, 79106
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Lubbock, Texas, États-Unis, 79423
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Sugar Land, Texas, États-Unis, 77479
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Virginia
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Newport News, Virginia, États-Unis, 23606
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Richmond, Virginia, États-Unis, 23294
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Richmond, Virginia, États-Unis, 23219
- Novo Nordisk Investigational Site
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Richmond, Virginia, États-Unis, 23298
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Winchester, Virginia, États-Unis, 22601
- Novo Nordisk Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53209
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 juin 2012
Achèvement primaire (Réel)
20 août 2013
Achèvement de l'étude (Réel)
20 août 2013
Dates d'inscription aux études
Première soumission
13 juin 2012
Première soumission répondant aux critères de contrôle qualité
13 juin 2012
Première publication (Estimation)
15 juin 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NN2211-3916
- 2011-002968-24 (Numéro EudraCT)
- U1111-1122-3303 (Autre identifiant: WHO)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .