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

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-002952-34-NL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-22
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 132

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

- 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