PIONEER TEENS. A research study to compare a new medicine oral semaglutide to a dummy medicine in children and teenagers with type 2 diabetes.

Phase 1

Recruiting

• Conditions: Type 2 diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-506923-27-00
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 127

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 <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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Secondary Objective: 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 parameters of body composition, To asses 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 from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c) (%-point and mmol/mol)