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NCT Number: NCT06475586

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

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

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Key information

Conditions

Psoriasis Vulgaris Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Banja Luka, Faculty of Medicine

Banja Luka, 78000, Bosnia and Herzegovina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

semaglutide

Drug

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

Other names: ozempic

Primary outcomes

  1. clinical characteristics of patients with psoriasis

    Time frame: 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.

  2. Determine BMI Body Mass Index

    Time frame: up to 12 weeks

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

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

    Time frame: up to12 weeks

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

    same units

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

    Time frame: 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

  5. Change in HgbA1C,

    Time frame: up to 12 weeks

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

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

    Time frame: up to 12 weeks

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

  7. fasting insulin

    Time frame: up to 12 weeks

    Biochemical analyses

  8. Change in inflammation marker level: CRP,

    Time frame: up to 12 weeks

    Biochemical analyses-Turbid metric test

  9. fasting glycemia

    Time frame: up to 12 weeks

    by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic)

  10. urate

    Time frame: up to 12 weeks

    Biochemical analyses

Sponsors and collaborators

Lead sponsor

University of Banja Luka

Other

Registry information

Official study title

Effect of Semaglutide on the Inflammatory Response and Clinical Course of Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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