A Phase 4 interventional study of Semaglutide in Psoriasis Vulgaris and Diabetes Type 2, sponsored by University of Banja Luka. Completed at 1 site in Bosnia and Herzegovina. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by University of Banja Luka · Phase 4, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →University of Banja Luka is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
0.25mg 4 weeks, 0.5mg per 4 weeks and 1.0mg per 4 weeks, totally 12 weeks
Also known as: ozempic
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
Biochemical analyses
Time frame: up to 12 weeks
Change in inflammation marker level: CRP,
Biochemical analyses-Turbid metric test
Time frame: up to 12 weeks
fasting glycemia
by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic)
Time frame: up to 12 weeks
urate
Biochemical analyses
Time frame: up to 12 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
Supporting information: Study protocol, Icf
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Banja Luka