Effect of Semaglutide on the Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus

University of Banja Luka30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis Vulgaris Diabetes Type 2

Interventions

SemaglutideDRUG

0.25mg 4 weeks, 0.5mg per 4 weeks and 1.0mg per 4 weeks, totally 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Banja Luka, Faculty of Medicine

Banja Luka, Bosnia and Herzegovina

Outcomes

Primary Outcomes

clinical characteristics of patients with psoriasis

clinical examination by a dermatovenerologist (PASI SCORE- Psoriasis Area and Severity Index). To assess disease activity, i.e. skin surface affected by changes (erythema, infiltration and extent of squamous matter), investigators used the PASI score. According to the European consensus, mild psoriasis is defined as PASI≤10 and DLQI≤10, while moderate psoriasis is defined as PASi\>10 and DLQI\>10.

Time frame: up to 12 weeks

Determine BMI Body Mass Index

e.g., weight and height will be combined to report BMI in kg/m\^2

Time frame: up to 12 weeks

Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23

ELISA-Enyzme linked immunosorbent assay technique -Bio Legend ELISA MAX Deluxe Sets, Bio Legend, San Diego, CA. same units

Time frame: up to12 weeks

Correlation between the course and prognosis of the disease after the treatment

the Wilcoxon Mann-Whitney test for two independent groups will be used. Spearman's correlation analysis will be used to determine the correlation between parameters, binary logistic regression

Time frame: up to 12 weeks

Change in HgbA1C,

by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic) will be expressed in %

Time frame: up to 12 weeks

lipid status, change in Total cholesterol (TC), low-density lipoprotein(LDL), high-density lipoprotein (HDL) and triglicerides

Biochemical analyses Clinical colorimetric tests, and results will be expressed in same units

Time frame: up to 12 weeks

fasting insulin

Data from ClinicalTrials.gov

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