PIONEER TEENS
T
Tamara Hannon, MD
Primary Investigator
Overview
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 less than 18 years) with type 2 diabetes on a background treatment of metformin or basal insulin or both.
versus placebo on glycaemic control in children and adolescents (age 10 to less than 18 years) with type 2 diabetes on a background treatment of metformin or basal insulin or both.
Description
This seeks to 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. Further, the trial will explore the beta-cellfunction- preserving effects of oral semaglutide during treatment and after a period of 12 weeks offtrial product following the 52-week treatment period.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Type 2 diabetes
-
Age: Between 10 Years - 18 Years
-
Gender: All
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Updated on
27 Apr 2024.
Study ID: 11299; NN9924-4437, PENDO-NOVONORDISK-PIONEER-TEEN
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