Clinical trial NCT06475586: Effect of Semaglutide on the Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
Official title: Effect of Semaglutide on the Inflammatory Response and Clinical Course of Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Diabetes Type 2
Keywords: psoriasis
diabetes type 2
semaglutide
cytokine
Lead sponsor: University of Banja Luka
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of semaglutide in patients with DMT2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response

Detailed description: After being informed about the study and potential risiks all patients giving written informed consent will undergo a 1-week screening period to determine eliglibility for study entry at week 0, patients who meet the eligibility requirements will be randomized.

Study was conducted in two cohort Cohort 1. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and to whom semaglutide will be introduced into the therapy, in the maximum tolerated dose of semaglutide (0.25mg, 0.5mg per week or 1.0mg per week).

Cohort 2. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and SGLT-2 inhibitors.

Eligibility criteria: Inclusion Criteria:

* Patients who signed a personal consent to participate in the study,
* Patients with a typical clinical picture of moderately-severe to severe plaque psoriasis (PASI SCORE ≥10) and
* DMT2 diagnosed at least 6 months before inclusion in the study,
* Patients who were not treated with immunosuppressive therapy.

Exclusion Criteria:

* Other forms of psoriasis,
* Other chronic, inflammatory diseases (data obtained by reviewing the medical history),
* Drugs that can cause the appearance of psoriasis (lithium, systemic antimalarials, systemic corticosteroids) - for the past 3 months,
* Systemic therapy of vulgaris psoriasis 3 months before inclusion in the study,
* Patients on therapy with other GLP-1 RAs except semaglutide (liraglutide, dulaglutide, lixisenatide), SGLT-2 inhibitors (empagliflozin and dapagliflozin) and NSAIDs, photo UVB therapy,
* Patients who did not personally sign consent to participate in the study.

Primary outcomes:
measure: clinical characteristics of patients with psoriasis
timeFrame: up to 12 weeks
measure: Determine BMI Body Mass Index
timeFrame: up to 12 weeks
measure: Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23
timeFrame: up to12 weeks
measure: Correlation between the course and prognosis of the disease after the treatment
timeFrame: up to 12 weeks
measure: Change in HgbA1C,
timeFrame: up to 12 weeks
measure: lipid status, change in Total cholesterol (TC), low-density lipoprotein(LDL), high-density lipoprotein (HDL) and triglicerides
timeFrame: up to 12 weeks
measure: fasting insulin
timeFrame: up to 12 weeks
measure: Change in inflammation marker level: CRP,
timeFrame: up to 12 weeks
measure: fasting glycemia
timeFrame: up to 12 weeks
measure: urate
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: University of Banja Luka, Faculty of Medicine
Study officials:
affiliation: Faculty of Medicine Banja Luka
name: Jelena Petkovic-Dabic
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costanzo G, Curatolo S, Busa B, Belfiore A, Gullo D. Two birds one stone: semaglutide is highly effective against severe psoriasis in a type 2 diabetic patient. Endocrinol Diabetes Metab Case Rep. 2021 Aug 1;2021:21-0007. doi: 10.1530/EDM-21-0007. Online ahead of print.
citation: Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021 Apr;46:101102. doi: 10.1016/j.molmet.2020.101102. Epub 2020 Oct 14.