EUCTR2018-002952-34-PTActive, not recruitingPhase 1
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 - PIONEER TEENS
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 132
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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