Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis

NCT05610956 | Recruiting Early Phase 1 DMC

• 1 other identifier: empagliflozin in UC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis.

  difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR)

  4months

Secondary Outcomes (3)

• expression of TNFalpha

  4months

• expression of Adenosine monophosphate activated protein kinase (AMPK ).

  4months

• expression of Fecal calprotectin

  4months

Study Arms (2)

placebo group

PLACEBO COMPARATOR

Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.

Drug: conventional treatment

empagliflozin group

EXPERIMENTAL

Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)for 4months.

Drug: Empagliflozin

Interventions

Empagliflozin DRUG

Patients will receive empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)and conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months.

empagliflozin group

conventional treatment DRUG

conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months

placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis.

You may not qualify if:

• Other inflammatory bowel diseases (CD).
• History of serious hypersensitivity to empagliflozin or any component of the formulation.
• Patients on dialysis.
• Severe renal impairment (eGFR \<20 ml/minute/1.73m2) .
• Chronic urinary tract infection.
• Chronic genital infection.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.

Tanta, Egypt

RECRUITING

Related Publications (15)

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MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

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

Central Study Contacts

youmna H eldeeb, phD

CONTACT

01014860930; youmnahamdyeldeeb@gmail.com

Sahar M Elhaggar

CONTACT

01008838807

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pharmacist

Model Details: parallel randomized controlled

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 9, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

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

Locations

EG (1)