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

University of Banja Luka

Status and phase: Completed; Phase 4

Conditions: Diabetes Type 2; Psoriasis Vulgaris

Treatments: Drug: Semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT06475586

18/4.48/23

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

semaglutide

Experimental group

Description:

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

Treatment:

Drug: Semaglutide

controled group

No Intervention group

Description:

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.