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

Phase 3

Recruiting

• Conditions: diabetes; Diabetes mellitus type 2; 10018424

• Registration Number: NL-OMON54032
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 3

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.

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.
-C-peptide <0.6 ng/mL and ALT >=3 times the UNL and bilirubin >=1.5 times the UNL

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c)<br /><br>(%-point and mmol/mol)</p><br>