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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1307-6786 | Other Identifier | World Health Organization (WHO) | |
| 2024-514432-24 | Other Identifier | European Medical Agency (EMA) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: CagriSema | Experimental | Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1. |
|
| Part 1: Placebo | Placebo Comparator | Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1. |
|
| Part 2: CagriSema | Experimental | Participants who received placebo in Part 1 will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CagriSema (Cagrilintide B and Semaglutide I) | Drug | Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured as percentage (%) of HbA1c. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body mass index (BMI) | Measured as percentage. | 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]) |
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Key Inclusion Criteria:
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.
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:
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.
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06511 | United States | ||
| Encore Medical Research Boynton Beach |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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It is 2-part study, first part is double-blinded and second part is open-label.
| Placebo matched to CagriSema (Cagrilintide B and Semaglutide I) | Drug | Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector. |
|
Measured as count of participants. |
| 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) | Measured as count of participants. | 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) | Measured as percentage of time. | 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 | Measured as percentage of time. | 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 | Measured as percentage of time. | 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 | Measured as percentage of time. | 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 | Measured as mmol/L. | 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) | Measured as percentage. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Number of participants with incidence of glycaemic rescue therapy | Measured as count of participants | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in fasting plasma glucose | Measured as mmol/L. | 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 | Measured as count of participants. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Number of participants with achievement of ≥ 10% BMI reduction | Measured as count of participants. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Number of participants with achievement of ≥ 15% BMI reduction | Measured as count of participants. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Relative change in body weight | Measured as percentage of body weight. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in BMI standard deviation score (SDS) | Measured as score on scale. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in waist circumference | Measured as centimetre (cm). | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in waist-to-height ratio | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in systolic blood pressure | Measured as millimetre of mercury (mmHg). | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in diastolic blood pressure | Measured as mmHg. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in lipid: total cholesterol | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in lipid: high density lipoprotein (HDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in lipid: low density lipoprotein (LDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in lipid: very low density lipoprotein (VLDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in lipid: triglycerides | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in lipid: Non-HDL cholesterol | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in alanine aminotransferase (ALT) | Measured as units per liter (U/L). | From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52) |
| Apparent clearance (CL/F) of cagrilintide and semaglutide | Measured as liter per hour (L/h). | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Average concentration (Cavg) of cagrilintide and semaglutide at steady state | Measured as nanomole per liter (nmol/L). | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in insulin dose | Measured as units (U). | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Number of participants with achievement of sustained insulin dose = 0 U | Measured as count of participants. | At end of double-blinded treatment (week 26) |
| Ratio to baseline in urine albumin-creatinine ratio (UACR) | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in biomarker related to glucose metabolism: fasting C-peptide | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in biomarker related to glucose metabolism: fasting insulin | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in biomarker related to glucose metabolism: fasting proinsulin | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in biomarker related to glucose metabolism: fasting glucagon | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in high sensitivity C-reactive protein (hsCRP) | Measured as ratio. | From baseline (week 0) to end of double- blinded treatment (week 26) |
| Ratio to baseline in free fatty acids | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in leptin | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in soluble leptin receptor | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Ratio to baseline in leptin to soluble leptin receptor ratio | Measured as ratio. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in aspartate aminotransferase (AST) | Measured as U/L. | From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52) |
| Change in alkaline phosphatase (ALP) | Measured as U/L. | From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52) |
| Change in bilirubin | Measured as U/L. | From baseline (week 0) to end of double-blinded treatment (week 26) and end of extension phase treatment (week 52) |
| Change in HbA1c | Measured as percentage of HbA1c. | From baseline (week 0) to end of extension phase treatment (week 52) |
| Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL) confirmed by blood glucose [BG] meter) | Measured as count of episodes. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Number of severe hypoglycaemic episodes (level 3) - severe hypoglycaemia being defined as severe cognitive impairment requiring assistance by another person to administer carbohydrates, glucagon, or intravenous glucose | Measured as count of episodes. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Change in percentage of time below range (TBR) < 3.0 mmol/L (< 54 mg/dL) measured using CGM | Measured as percentage of time. | At end of double-blinded treatment (collected during week 22, 23, 24, and 25) |
| Change in TBR < 3.9 mmol/L (< 70 mg/dL) measured using CGM | Measured as percentage of time. | At end of double-blinded treatment (collected during week 22, 23, 24, and 25) |
| Number of treatment-emergent adverse events | Measured as count of events. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Height velocity | Measured as cm/year. | At end of double-blinded treatment (week 26) |
| Change in height SDS | Measured as score on scale. | From baseline (week 0) to end of double-blinded treatment (week 26) |
| Boynton Beach |
| Florida |
| 33436 |
| United States |
| Nemours Chld Clnc Jacksonville | Jacksonville | Florida | 32207 | United States |
| Innovus Clinical | Kissimmee | Florida | 34741 | United States |
| D&H National Research Centers | Tamarac | Florida | 33321 | United States |
| Clinical Research Trials of Florida | Tampa | Florida | 33607 | United States |
| Columbus Research Foundation | Columbus | Georgia | 31904 | United States |
| Eastside Bariatric and Gen Surg | Snellville | Georgia | 30078 | United States |
| SIU Medicine | Springfield | Illinois | 62702 | United States |
| Riley Hospital For Children | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Great Lakes Research Inst. | Southfield | Michigan | 48075 | United States |
| UBMD Pediatrics | Buffalo | New York | 14203 | United States |
| NYU Langone Orthopedic Center | New York | New York | 10016 | United States |
| Children's Hosptl Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Monument Health Clinical Rsrch | Rapid City | South Dakota | 57701 | United States |
| LifeDoc Health | Memphis | Tennessee | 38115 | United States |
| Amir Ali Hassan, MD, PA | Houston | Texas | 77089 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| UVA Health Systems | Charlottesville | Virginia | 22903 | United States |
| Seattle Children's Research Institute | Seattle | Washington | 98105 | United States |
| Centro de Investigaciones Metabólicas | Capital Federal | Buenos Aires | C1056ABI | Argentina |
| Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio | San Miguel de Tucumán | Tucumán Province | T4000DPX | Argentina |
| IMOBA | City of Buenos Aires | C1056ABH | Argentina |
| Clínica Mayo de Urgencias Médicas Cruz Blanca | San Miguel de Tucumán | T4000IHE | Argentina |
| Hospital Universitário Walter Cantídio | Bairro Rodolfo Teófilo, Fortaleza | Ceará | 60416-000 | Brazil |
| Centro de Diabetes Curitiba | Curitiba | Paraná | 80810-040 | Brazil |
| Instituto da Criança com Diabetes - ICD | Porto Alegre | Rio Grande do Sul | 91350-250 | Brazil |
| Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| IBTED Tecnologia e Educação em Diabetes - EPP | São Paulo | São Paulo | 04038-032 | Brazil |
| Instituto da Criança e do Adolescente do HCFMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Salud SURA Industriales | Bogotá | Antioquia | 50017 | Colombia |
| Fundacion Valle del Lili | Cali | Valle del Cauca Department | 760032 | Colombia |
| Endolife Specialty Hospitals | Guntur | Andhra Pradesh | 522001 | India |
| BAPS Pramukh Swami Hospital | Surat | Gujarat | 395009 | India |
| Indira Gandhi Institute of child health | Bangalore | Karnataka | 560011 | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Maulana Azad Medical College | Delhi | New Delhi | 110002 | India |
| Regency Hospital | Kanpur | Uttar Pradesh | 208006 | India |
| Institute of Child Health | Kolkata | West Bengal | 700017 | India |
| Excel Endocrine Centre | Kolhāpur | 416008 | India |
| All India Institute of Medical Sciences (AIIMS) | New Delhi | 110029 | India |
| HaEmek MC - Pediatric Endocrinology department | Afula | 1834111 | Israel |
| Soroka MC - Pediatric Endocrinology | Beersheba | 84101 | Israel |
| Rambam MC - Department of Pediatrics A | Haifa | 31096 | Israel |
| Carmel MC - Pediatric Endocrinology Unit | Haifa | 3436212 | Israel |
| Shaare Zedek MC - Pediatric Endocrinology | Jerusalem | 9103102 | Israel |
| University Malaya Medical Centre | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
| Hospital Putrajaya | Putrajaya | 62250 | Malaysia |
| Instituto Nacional de Pediatría | Coyoacán | Mexico City | 04530 | Mexico |
| IECSI Centro de Investigación Clínica | Monterrey | Nuevo León | 64310 | Mexico |
| Centro de Investigación y Control Metabólico S. C. | San Nicolás de los Garza | Nuevo León | 66465 | Mexico |
| Consultorio de Endocrinología y Pediatría | Puebla City | 72190 | Mexico |
| Taipei Mackay Children's Hospital | Taipei | 104 | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology | Chiang Mai | 50200 | Thailand |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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