Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

July 9, 2025 updated by: Mahmoud Samy Abdallah, Sadat City University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt, 13829
        • Faculty of pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sadat City University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G12/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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