Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Study Overview
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Brief Summary
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This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.

Official Title
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Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Empagliflozin 10 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis. Adults (males and/or females) with age range from 18 to 65 years old. Patients on treatment with 5-aminosalisylic acid (5-ASA) Exclusion Criteria: Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis. Treatment with systemic or rectal steroids. Treatment with immunosuppressants. Previously failed treatment with a sulphasalazine. Known hypersensitivity to any of study drugs. Hepatic and renal dysfunction. Pregnancy and lactation. History of colorectal carcinoma. History of complete or partial colectomy. Patients with diabetes mellitus Patients with history of lactic acidosis Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency Positive stool culture for enteric pathogens, positive stool ova and parasite exam.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin group<br>participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy | Drug: Empagliflozin 10 MG<br>* participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy<br>|
| Placebo Comparator: Placebo<br>participants will receive placebo for 8 consecutive weeks in addition to the standard therapy | Drug: Placebo<br>* participants will receive placebo for 8 consecutive weeks in addition to the standard therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of colonic (NF)-κB proteins | Difference between the two groups in the expression of colonic (NF)-κB proteins. | 8 weeks |