---
title: Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
nct_id: NCT05610956
overall_status: RECRUITING
phase: EARLY_PHASE1
sponsor: Tanta University
study_type: INTERVENTIONAL
primary_condition: Ulcerative Colitis
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05610956.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05610956"
ct_last_update_post_date: 2025-07-16
last_seen_at: "2026-05-12T07:08:35.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis

**Official Title:** Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis

**NCT ID:** [NCT05610956](https://clinicaltrials.gov/study/NCT05610956)

## Key Facts

- **Status:** RECRUITING
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Tanta University
- **Conditions:** Ulcerative Colitis
- **Start Date:** 2023-01-01
- **Completion Date:** 2026-12-01
- **CT.gov Last Update:** 2025-07-16

## 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.

## Detailed Description

* It will be conducted on 60 patients having with mild to moderate degree UC divided into two groups:

  1. Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid).
  2. Group 2 (n=30): Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day).
* The patient will be selected from the Gastroenterology and Endoscopy Unit, Internal Medicine.

  . All patients will be subjected to the following:
* Complete history taking.
* Colonoscopy with intubation of the ileum and biopsies of affected and unaffected areas should be obtained to confirm the diagnosis of UC.
* Blood sample collection to assess:

A) Routine Laboratory tests

1. Complete blood picture (CBC).
2. Liver functions (ALT, AST, Total and Direct Bilirubin).
3. Kidney functions tests (Urea, serum creatinine).
4. C-reactive protein.
5. Fasting blood glucose.
6. Urine analysis. B) Specific Laboratory tests

1\. Tumor necrosis factor alpha (TNF-α). 2. Adenosine monophosphate activate protein kinase (AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

•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.

Exclusion Criteria:

* 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.
```

## Arms

- **placebo group** (PLACEBO_COMPARATOR) — Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.
- **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.

## 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.
- **conventional treatment** (DRUG) — conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months

## Primary Outcomes

- **clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis.** _(time frame: 4months)_ — difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR)

## Secondary Outcomes

- **expression of TNFalpha** _(time frame: 4months)_
- **expression of Adenosine monophosphate activated protein kinase (AMPK ).** _(time frame: 4months)_
- **expression of Fecal calprotectin** _(time frame: 4months)_

## Locations (1)

- Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital., Tanta, Egypt — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gastroenterology and endoscopy unit, internal medicine department, tanta university hospital.|tanta||egypt` — added _(2026-05-12)_

---

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