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

Phase 4

Completed

• Conditions: Psoriasis Vulgaris; Diabetes Type 2
• Interventions: Drug: Semaglutide

• Registration Number: NCT06475586
• Lead Sponsor: University of Banja Luka

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.

Study Timeline

• Study Start: 2023-05-03
• Primary Completion: 2024-03-01
• Status Verified: 2024-06
• Study Completion: 2024-06-10
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-26
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
semaglutide	Semaglutide	The initial dose of the medicine is 0.25 mg once a week, for the duration of 4 weeks. Then the dose is increased to 0.5 mg per week, for the duration of 4 weeks. After at least 4 weeks, the dose can be increased from 0.5 mg to 1 mg per 4 week. Totally 12 weeks

Primary Outcome Measures

Name	Time	Method
clinical characteristics of patients with psoriasis	up to 12 weeks	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.
fasting glycemia	up to 12 weeks	by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic)
urate	up to 12 weeks	Biochemical analyses
Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23	up to12 weeks	ELISA-Enyzme linked immunosorbent assay technique -Bio Legend ELISA MAX Deluxe Sets, Bio Legend, San Diego, CA.; same units
Change in HgbA1C,	up to 12 weeks	by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic) will be expressed in %
Change in inflammation marker level: CRP,	up to 12 weeks	Biochemical analyses-Turbid metric test
Determine BMI Body Mass Index	up to 12 weeks	e.g., weight and height will be combined to report BMI in kg/m\^2
Correlation between the course and prognosis of the disease after the treatment	up to 12 weeks	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
lipid status, change in Total cholesterol (TC), low-density lipoprotein(LDL), high-density lipoprotein (HDL) and triglicerides	up to 12 weeks	Biochemical analyses Clinical colorimetric tests, and results will be expressed in same units
fasting insulin	up to 12 weeks	Biochemical analyses

Trial Locations

Locations (1)

University of Banja Luka, Faculty of Medicine; 🇧🇦 Banja Luka, Bosnia and Herzegovina