Clinical Trials List
Protocol NumberNN9924-4437
Completed
2020-11-02 - 2024-12-02
Phase III
Recruiting2
PIONEER TEENS - Efficacy and safety of oral semaglutide versus placebo both in combination with metformin and/or basal insulin in children and adolescents with type 2 diabetes
-
Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Type 2 diabetes
Objectives
PIONEER TEENS (NN9924-4437) will be conducted 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.
Test Drug
Semaglutide
Active Ingredient
Semaglutide
Dosage Form
Dosage
3,7,14 mg/tablet
Endpoints
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c) (%-point and mmol/mol)
Inclution 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 <18 years at the day of randomisation
• HbA1c 6.5%−11.0% (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 ≥30 days prior to screening,
compared to the dose at screening, dose adjustments of ± 25% are allowed.
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 <18 years at the day of randomisation
• HbA1c 6.5%−11.0% (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 ≥30 days prior to screening,
compared to the dose at screening, dose adjustments of ± 25% are allowed.
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
• Maturity onset diabetes of the young (MODY)
• Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid
decarboxylase (anti-GAD) antibodies
The Estimated Number of Participants
-
Taiwan
20 participants
-
Global
330 participants
