Resumen

El propósito de este estudio clínico es investigar qué tan bien un medicamento en estudio llamado CagriSema ayuda a los niños y adolescentes que viven con diabetes a reducir su nivel de azúcar en sangre y su peso corporal. El estudio tiene 2 partes: en la primera parte, el participante recibirá ya sea CagriSema o placebo, y en la segunda parte, el participante recibirá CagriSema. En la primera parte, el tratamiento que recibe el participante se decide al azar; la segunda parte es de etiqueta abierta y todos los participantes recibirán CagriSema durante esta parte. El estudio tendrá una duración de aproximadamente 1 año y 3 meses.

Elegibilidad

Edad mínima: 10 YearsEdad máxima: 18 YearsSexo: ALL

Criterios de inclusión

Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
Male or female.
Age 10 to \< 18 years at the time of signing the informed consent.
Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \[ISPAD\] criteria) ≥ 30 days before screening.
Treated with diet and exercise counselling alone or with a stable daily dose(a), in addition to diet and exercise counselling, of any of the following antidiabetic drugs or combination regimens:
Insulin (any regimen)
Metformin
SGLT2i
HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening.
Body weight ≥ 45 kg and BMI ≥ 85th percentile(b). BMI will be calculated in the electronic case report form based on height and body weight at screening.
(a) For metformin, a stable dose is defined as at least 1000 mg daily or the maximum tolerated dose for ≥ 56 days prior to screening. For Sodium-Glucose Transport protein 2 inhibitor (SGLT2i), a stable dose is defined as the same total daily dose for ≥ 56 days prior to screening. For insulin, it is defined as the dose ± 25% of that taken at screening for ≥ 30 days prior to screening.
(b) Based on sex-specific BMI-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used.
Known or previous diagnosis of hypoparathyroidism.
Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening.
Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history.
Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
Uncontrolled and potentially unstable diabetic retinopathy maculopathy. Verified by a fundus examination and optical coherence tomography (OCT) assessment performed within 90 days before 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.

Criterios de exclusión

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.

Intervenciones

drug

CagriSema (Cagrilintide B and Semaglutide I)

Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

drug

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Eficacia y seguridad de la coadministración de cagrilintide y semaglutide (CagriSema) s.c. una vez por semana versus placebo en niños y adolescentes con diabetes tipo 2

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

CagriSema (Cagrilintide B and Semaglutide I)

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Ubicaciones

Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio

Centro de Investigaciones Metabólicas

IMOBA

Clínica Mayo de Urgencias Médicas Cruz Blanca

Patrocinadores

Contactos

Novo Nordisk