NCT04892199CompletedPhase 2
SemaPsychiatry
Does the glucagon-like peptide-1 receptor agonist semaglutide prevent deterioration of metabolic state in prediabetic or diabetic patients with schizophrenia treated with the antipsychotic compounds clozapine or olanzapine?
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2024
Brief summary (registry, in English)
The objective of this study is to investigate long term (26 weeks) effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on the metabolic state in prediabetic or diabetic patients with schizophrenia, aged 18 years to 65 years, who have initiated treatment with clozapine or olanzapine.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 9 Oct 2024
- Start date
- 4 Nov 2024
- Lead sponsor
- Psykiatrisk Center Kobenhavn
- Diseases
- Schizophrenia
- NCT number
- NCT04892199
- EU CT number
- 2024-518746-24-00
- EudraCT number
- 2020-000102-28
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 104
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- Suicidal behavior and/or plasma HbA1c > 57 mmol/mol (tested twice) in which case the patient will be excluded from the study and transferred to general practitioner or hospital for diabetic treatment & no diabetic medication is allowed except for the trial medicine.
Who the study is looking for
- Initiated current daily treatment with clozapine or olanzapine, respectively, within 60 months & Diagnosed with prediabetes or type 2 diabetes, with the following plasma levels: Prediabetes: HbA1c 35-47 mmol/mol or fasting plasma glucose (FPG) 5.6-6.9 mM or 2-h during 75 mg OGGT 7.8-11.0 mM. The test result has to be confirmed on a different day. Type 2 diabetes: HbA1c 48-57 mmol/mol or fasting plasma glucose (FPG) 6.9-9.9 mM or 2h OGTT > 11 mM (although FPG and HbA1c might still be under the diagnostic range). The test result has to be confirmed on a different day.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psykiatrisk Center Kobenhavn Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.