Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. - Male or female, aged 10 to less than18 years at the day of randomisation. - Glycosylated haemoglobin (HbA1c) 6.5-11.0 percent (47-97 mmol/mol) (both inclusive). - Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with: - stable metformin dose* or - stable metformin dose* and a stable dose of basal insulin** or - stable dose of basal insulin** *stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening. **stable dose of basal insulin is defined as basal insulin treatment more than or equal to 30 days prior to screening, compared to the dose at screening, dose adjustments of plus or minus 25 percent are allowed. Are the trial subjects under 18? yes Number of subjects for this age range: 132 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Diagnosis of type 1 diabetes. - Maturity onset diabetes of the young (MODY). - Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority of oral semaglutide at the maximum tolerated dose* (3 mg, 7 mg or 14 mg) versus placebo on glycaemic control in children and adolescents (age 10 to <18 years) with type 2 diabetes on a background treatment of metformin or basal insulin or both. *maximum tolerated dose is defined as maximum dose level defined according to individual glycaemic response and tolerability as assessed by the investigator;Secondary Objective: 1. To assess and compare the efficacy of oral semaglutide at the maximum tolerated dose (3 mg, 7 mg or 14 mg) versus placebo on a background treatment of metformin or basal insulin or both on: A. Other parameters of glycaemic control B. Parameters of body composition C. Growth parameters D. Cardio-metabolic parameters 2. To assess and compare the safety and tolerability of oral semaglutide at the maximum tolerated dose (3 mg, 7 mg or 14 mg) versus placebo on a background treatment of metformin or basal insulin or both.;Primary end point(s): Change in glycosylated haemoglobin (HbA1c) (%-point and mmol/mol);Timepoint(s) of evaluation of this end point: From baseline (week 0) to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in HbA1c (week 52) 2. Change in fasting plasma glucose (FPG) 3. Change in body mass index (BMI) standard deviation score (SDS) 4. Change in body weight (kg) 5. Change in body weight (relative change in %) 6. Change in waist circumference 7. Change in BMI percentile (age and gender adjusted) 8. Change in systolic and diastolic blood pressure 9. HbA1c <7.0% (53 mmol/mol) (yes/no), American Diabetes Association (ADA) target and International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines from 2018 (week 26) 10. HbA1c =6.5% (48 mmol/mol) (yes/no), American Association of Clinical Endocrinologists (AACE) target (week 26) 11. HbA1c <7.0% (53 mmol/mol) (yes/no), ADA target and ISPAD guidelines from 2018 (week 52) 12. HbA1c =6.5% (48 mmol/mol) (yes/no), AACE target (week 52) 13. Time to additional anti-diabetic medication 14. Time to rescue medication 15. Number of treatment-emergent adverse events (TEAEs) 16. Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes (week 0-26) 17. Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes (week 0-57) 18. Treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episode (yes/no) (week 0-26) 19. Treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episode (yes/no) (week 0-57) 20. Change in biochemistry, amylase 21. Change in biochemistry, lipase 22. Change in biomarker, insulin-like growth factor 1 (IGF-1) 23. Change in biomarker, insulin–like growth factor binding protein 3 (IGFBP 3) 24. Change in hormone, calcitonin 25. Change in hormone, estradiol (for girls) 26. Change in hormone, testosterone (for boys) 27. Change in hormone, prolactin 28. Change in hormone, thyroid stimulating hormone (TSH/thyrotropin) 29. Change in hormone, follicle stimulating hormone (FSH) 30. Change in hormone, luteinizing hormone (LH) 31. Change in hormone, dehydroepian | — |
Countries
Australia, Austria, Belgium, Czech Republic, European Union, Greece, India, Israel, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Portugal, Russian Federation, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed