Type two diabetes in paediatric population T2D
Conditions
Interventions
Subjects will, after a 2-week screening period, be randomised in a 1:1 manner to receive either oral semaglutide or placebo.
confirm the efficacy and safety of oral semaglutide in the paediatric population to address the unmet need for treatment of children and adolescents 10 to <18 years of age with type 2 diabetes. Furthe
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Age
10 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Subjects are eligible to be included in the trial only if all of the following criteria apply: 1. 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. 2. Male or female, aged 10 to <18 years at the day of randomisation 3. Diagnosed with type 2 diabetes mellitus according to the ADA 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 =30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed. 4. HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive) 5. Ability and willingness to adhere to the protocol including self-measurement of plasma glucose according to the protocol.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Subjects are excluded from the trial if any of the following criteria apply: 1. Known or suspected hypersensitivity to trial product(s) or related products. 2. Previous participation in this trial. Participation is defined as randomisation. Re-screening is allowed, however there must be at least 90 days between screenings. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods, refer to Appendix 5. 4. Receipt of any investigational medicinal product within 30 days before screening. 5. Any disorder, which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol. 6. Any laboratory safety parameter at screening outside the below extended laboratory ranges: • ALT =2.5 times the upper normal limit (UNL) • creatinine >UNL for age in children unless renal function is proven normal by further assessments at the discretion of the investigator • C-peptide 99th percentile for age and gender in children and adolescents. If “white coat hypertension” is suspected at visit 1 a repeat blood pressure measurement either during visit 1 or at visit 2 prior to other trial related activities is allowed, with the last measurement being conclusive. 13. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria in a period of 90 days before screening. However, short-term treatment with bolus insulin for a metabolic decompensation/intercurrent illness for a maximum of 14 days prior to the day of visit 1 is allowed. 14. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy documented by an ophthalmologic examination of the retina preferably supported by a fundus photography or optical coherence tomography within the past 90 days prior to screening or in the period between screening and randomisation (visit 2). Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 15. Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed. 16. Diagnosis of type 1 diabetes 17. Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. 18. Maturity onset diabetes of the young (MODY). 19. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy or gastric bypass surgery).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c) (%-point and;Timepoints: week 0 to week 26;Measure: HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: Fasting plasma glucose (FPG) (mmol/L);Timepoints: week 0 to week 26;Measure: FPG;Name: Body mass index (BMI) standard deviation score (SDS);Timepoints: week 0 to week 26;Measure: BMI | — |
Countries
Czech Republic, Greece, Lebanon, Mexico, Netherlands, Portugal, Russian Federation, United States of America
Contacts
Public ContactBadiaa Masri
Novo Nordisk
Outcome results
None listed