Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

NCT05058417 | Withdrawn Phase 2 DMC

• 1 other identifier: G12/2021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Expression of colonic (NF)-κB proteins

  Difference between the two groups in the expression of colonic (NF)-κB proteins.

  8 weeks

Study Arms (2)

Empagliflozin group

EXPERIMENTAL

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

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Empagliflozin 10 MG DRUG

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

Empagliflozin group

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Pharmacy

Shibīn al Kawm, Menoufia, 13829, Egypt

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: October 1, 2021
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

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

Locations

EG (1)