A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes

Официальное название

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes

Обзор

The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.

Вмешательства

• Препарат CagriSema (Cagrilintide B and Semaglutide I)
  Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
• Препарат 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.

Первичные конечные точки

• Change in glycated haemoglobin (HbA1c) [Срок оценки: From baseline (week 0) to end of double-blinded treatment (week 26)]

Вторичные конечные точки (12)

• Relative change in body mass index (BMI) [Срок оценки: From baseline (week 0) to end of double-blinded treatment (week 26)]
• Number of participants with achievement of HbA1c target values of less than (<) 7.0% (< 53 millimole per mole [mmol/mol]) [Срок оценки: At end of double-blinded treatment (week 26)]
• Number of participants with achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤48 mmol/mol) [Срок оценки: At end of double-blinded treatment (week 26)]
• Change in time in range (TIR) 3.9-10.0 millimole per liter (mmol/L) (70-180 milligram per deciliter (mg/dL) measured using continuous glucose monitoring (CGM) [Срок оценки: From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)]
• Change in time in tight target range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) measured using CGM [Срок оценки: From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)]
• Change in time above range (TAR) greater than (>) 10.0 mmol/L (> 180 mg/dL) measured using CGM [Срок оценки: From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)]
• Change in TAR greater than (>) 13.9 mmol/L (> 250 mg/dL) measured using CGM [Срок оценки: From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25)]
• Change in mean sensor glucose concentration measured by CGM [Срок оценки: From baseline (collected during week -3, -2 and -1) to end-of- double-blinded treatment (collected during week 22, 23, 24, and 25)]
• CGM: Within-day glycaemic variability (% coefficient of variation) [Срок оценки: From baseline (week 0) to end of double-blinded treatment (week 26)]
• Number of participants with incidence of glycaemic rescue therapy [Срок оценки: From baseline (week 0) to end of double-blinded treatment (week 26)]
• Change in fasting plasma glucose [Срок оценки: From baseline (week 0) to end of double-blinded treatment (week 26)]
• Number of participants with achievement of greater than or equal to (≥) 5% BMI reduction [Срок оценки: From baseline (week 0) to end of double-blinded treatment (week 26)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
• Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 21 центр

• Yale School of Medicine — New Haven
• Encore Medical Research Boynton Beach — Boynton Beach
• Nemours Chld Clnc Jacksonville — Jacksonville
• Innovus Clinical — Kissimmee
• D&H National Research Centers — Tamarac
• Clinical Research Trials of Florida — Tampa
• Columbus Research Foundation — Columbus
• Eastside Bariatric and Gen Surg — Snellville
• … и ещё 13 центров

Индия · 9 центров

• Endolife Specialty Hospitals — Guntur
• BAPS Pramukh Swami Hospital — Surat
• Indira Gandhi Institute of child health — Bangalore
• Sir Ganga Ram Hospital — New Delhi
• Maulana Azad Medical College — Delhi
• Regency Hospital — Kanpur
• Institute of Child Health — Kolkata
• Excel Endocrine Centre — Kolhāpur
• … и ещё 1 центр

Бразилия · 6 центров

• Hospital Universitário Walter Cantídio — Bairro Rodolfo Teófilo, Fortaleza
• Centro de Diabetes Curitiba — Curitiba
• Instituto da Criança com Diabetes - ICD — Porto Alegre
• Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão — Ribeirão Preto
• IBTED Tecnologia e Educação em Diabetes - EPP — São Paulo
• Instituto da Criança e do Adolescente do HCFMUSP — São Paulo

Израиль · 5 центров

• HaEmek MC - Pediatric Endocrinology department — Afula
• Soroka MC - Pediatric Endocrinology — Beersheba
• Rambam MC - Department of Pediatrics A — Haifa
• Carmel MC - Pediatric Endocrinology Unit — Haifa
• Shaare Zedek MC - Pediatric Endocrinology — Jerusalem

Аргентина · 4 центра

• Centro de Investigaciones Metabólicas — Capital Federal
• Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio — San Miguel de Tucumán
• IMOBA — City of Buenos Aires
• Clínica Mayo de Urgencias Médicas Cruz Blanca — San Miguel de Tucumán

Мексика · 4 центра

• Instituto Nacional de Pediatría — Coyoacán
• IECSI Centro de Investigación Clínica — Monterrey
• Centro de Investigación y Control Metabólico S. C. — San Nicolás de los Garza
• Consultorio de Endocrinología y Pediatría — Puebla City

Колумбия · 2 центра

• Salud SURA Industriales — Bogotá
• Fundacion Valle del Lili — Cali

Малайзия · 2 центра

• University Malaya Medical Centre — Lembah Pantai
• Hospital Putrajaya — Putrajaya

Таиланд · 2 центра

• King Chulalongkorn Memorial Hospital — Bangkok
• Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology — Chiang Mai

Тайвань · 1 центр

• Taipei Mackay Children's Hospital — Taipei

Идентификаторы

NCT: NCT07282613 · NN9388-7988 · U1111-1307-6786 · 2024-514432-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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