Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05058417

Enrollment

Registered

2021-09-27

Start date

2021-10-01

Completion date

2025-12-31

Last updated

2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

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.

Interventions

DRUGEmpagliflozin 10 MG

participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy

DRUGPlacebo

participants will receive placebo for 8 consecutive weeks in addition to the standard therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026