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Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients
NCT06243536Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2024
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- University Hospital Center Sestre milosrdnice
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Drugs
- semaglutide
- Conditions
- eating disorder
01
Overview
Phase 4, randomised, open-label trial of semaglutide in eating disorder (3 arms), sponsored by University Hospital Center Sestre milosrdnice. Primary endpoint: Eating Attitude Test questionnaire score at 12 weeks. Planned start Feb 2024; status: not yet recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Type 2 diabetic patients without disordered eating behaviour
Treated with standard of care.
Type 2 diabetic patients with disordered eating behaviour A
Treated with standard of care.
Type 2 diabetic patients with disordered eating behaviour B
Receiving semaglutide for 12 weeks
03
Who it enrols
Adults aged 18-65 with type 2 diabetes, BMI >= 28, HbA1c > 7%, naive to GLP-1 receptor agonists, without severe hepatic or renal impairment, and not taking medications that affect eating.
04
Endpoints
Primary
Eating Attitude Test questionnaire score
Secondary
Continuous glucose monitoring parameter
Concentration of incretin hormones (GLP-1, GIP)
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