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

NCT06475586 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 18/4.48/23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis Vulgaris; Diabetes Type 2

Keywords

psoriasis; diabetes type 2; semaglutide; cytokine

Outcome Measures

Primary Outcomes (10)

• 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.

  up to 12 weeks

• Determine BMI Body Mass Index

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

  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

  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

  up to 12 weeks

• Change in HgbA1C,

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

  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

  up to 12 weeks

• fasting insulin

  Biochemical analyses

  up to 12 weeks

• Change in inflammation marker level: CRP,

  Biochemical analyses-Turbid metric test

  up to 12 weeks

• fasting glycemia

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

  up to 12 weeks

• urate

  Biochemical analyses

  up to 12 weeks

Study Arms (2)

semaglutide

EXPERIMENTAL

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

Drug: Semaglutide

controled group

NO INTERVENTION

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.

Interventions

Semaglutide DRUG

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

Also known as: ozempic

semaglutide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: male and female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients who were not treated with immunosuppressive therapy.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• University of Banja Luka: lead

Study Sites (1)

University of Banja Luka, Faculty of Medicine

Banja Luka, 78000, Bosnia and Herzegovina

Location

Related Publications (2)

• 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.

  PMID: 34463640 RESULT

• 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.

  PMID: 33068776 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Psoriasis

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jelena Petkovic-Dabic

  Faculty of Medicine Banja Luka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double (participant, investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 26, 2024
• Study Start: May 3, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 10, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BO (1)