NCT06010992

Brief Summary

Diabetes mellitus (DM) is a complex metabolic disorder characterized by hyperglycemia and abnormalities in carbohydrate, fat, and protein metabolism. Despite the advancement in anti-diabetic drug therapy, most patients fail to achieve optimal glycemic control. This highlights the need for more effective strategies to control type 2 diabetes mellitus. Nitazoxanide (NTZ), a broad-spectrum anti-infective drug with activity against various protozoa, helminthes, bacteria, and viruses, was identified as peroxisome proliferative activated receptor gamma (PPARγ) agonist using one dimensional drug profile matching. Additionally, it improved insulin sensitivity in insulin-resistant type 2 diabetic rats. Therefore, this study is designed to evaluate the efficacy of nitazoxanide as adjunctive therapy in patients with type 2 diabetes mellitus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2023

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 21, 2023

Last Update Submit

August 21, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    Fasting blood glucose and glycated hemoglobin

    12 weeks

Secondary Outcomes (4)

  • Insulin resistance

    12 weeks

  • Lipid profile

    12 weeks

  • Serum levels of A-kinase anchoring protein 1

    12 weeks

  • Serum levels of asprosin

    12 weeks

Study Arms (2)

Group 1

NO INTERVENTION

35 Patients with type 2 diabetes receiving treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).

Group 2

EXPERIMENTAL

35 Patients with type 2 diabetes receiving nitazoxanide 500 mg orally twice daily in addition to metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).

Drug: Nitazoxanide

Interventions

NitazoxanideDRUG

Nitazoxanide oral capsules 500 mg twice daily

Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Glycated hemoglobin (HbA1c) between 7% and 9%.
  • Body mass index ≥ 25 kg/m2

You may not qualify if:

  • Pregnant or nursing women.
  • Type 1 diabetes mellitus.
  • Liver disease (alanine aminotransferase \> 3 upper normal limit).
  • Kidney disease (estimated glomerular filtration rate \< 60 ml/min/1.73 m2).
  • Inflammatory bowel diseases.
  • History of allergy and/or adverse reactions to the drugs used in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of medicine, Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

RECRUITING

Related Publications (1)

  • Ghonaim EM, Ibrahim OM, Hegazy SK, Farrag WF, Badr HR. Repurposing nitazoxanide in type 2 diabetes mellitus: a randomized controlled trial. Endocrine. 2025 Nov;90(2):596-604. doi: 10.1007/s12020-025-04387-5. Epub 2025 Aug 15.

    PMID: 40815384DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eman Ghonaim

    Assistant Lecturer, Faculty of Pharmacy, Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Ghonaim, Assistant lecturer

CONTACT

+20-010-970-821-57eman.ghonim@pharm.tanta.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

January 1, 2025

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)