Resumen

Los investigadores realizan este estudio para evaluar si semaglutida puede frenar el crecimiento y el empeoramiento de la enfermedad renal crónica en personas con diabetes tipo 2. Los participantes recibirán semaglutida (medicamento activo) o placebo ("medicamento ficticio"). Esto se denomina medicamento del estudio del participante: el tratamiento asignado a cada participante se determina al azar. Semaglutida es un medicamento que los médicos pueden recetar en algunos países para el tratamiento de la diabetes tipo 2. Los participantes recibirán el medicamento del estudio en un bolígrafo. Los participantes utilizarán el bolígrafo para inyectarse el medicamento en un pliegue cutáneo una vez a la semana. El estudio se cerrará cuando se haya recopilado suficiente información para mostrar un resultado claro del estudio. El tiempo total que los participantes estarán en este estudio es de aproximadamente 3 a 5 años, aunque podría ser más.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female, age above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus
HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
Renal impairment defined either by:
serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g

Criterios de exclusión

Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
Planned coronary, carotid or peripheral artery revascularisation
Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Intervenciones

drug

Semaglutide

Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject semaglutide under their skin. Participants will inject semaglutide 1 time a week on the same day of the week. Participants' dose of semaglutide will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.

drug

Placebo (semaglutide)

Participants are to inject placebo (semaglutide) with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject placebo (semaglutide) under their skin. Participants will inject placebo (semaglutide) 1 time a week on the same day of the week. Participants' dose of placebo (semaglutide) will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.

Ubicaciones

Centro de Estudios Renales e Hipertensión Arterial

Villa Domínico, Buenos Aires, Argentina

Centro Diabetológico y Nuticional Dr Alejandro Chertkoff

Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, Argentina

FEPREVA

CABA, Argentina

Centro de Investigación Clínica

CABA, Argentina

Glenny Corp. S.A

CABA, Argentina

Medical Center of Diabetes and Nutrition

CABA, Argentina

Efecto de semaglutida frente a placebo sobre la progresión del deterioro renal en sujetos con diabetes tipo 2 y enfermedad renal crónica

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Semaglutide

Placebo (semaglutide)

Ubicaciones

Centro de Estudios Renales e Hipertensión Arterial

Centro Diabetológico y Nuticional Dr Alejandro Chertkoff

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

FEPREVA

Centro de Investigación Clínica

Glenny Corp. S.A

Medical Center of Diabetes and Nutrition

Patrocinadores