Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06010992

Collaborator

Menoufia University (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Nitazoxanide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group 1 35 Patients with type 2 diabetes receiving treatment with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors (such as vildagliptin).
Experimental: Group 2 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 Nitazoxanide oral capsules 500 mg twice daily

Arm

Intervention/Treatment

No Intervention: Group 1

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

Experimental: Group 2

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

Nitazoxanide oral capsules 500 mg twice daily

Outcome Measures

Primary Outcome Measures

Glycemic control [12 weeks]
Fasting blood glucose and glycated hemoglobin

Secondary Outcome Measures

Insulin resistance [12 weeks]
fasting insulin level with HOMA-IR calculation
Lipid profile [12 weeks]
Serum levels of total cholesterol, LDL, HDL, and triglycerides
Serum levels of A-kinase anchoring protein 1 [12 weeks]
Serum levels of asprosin [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Tanta University	Tanta	El-Gharbia	Egypt	31527
2	Faculty of Medicine, Menoufia University	Shibīn Al Kawm	Menoufia	Egypt	32511

Sponsors and Collaborators

Tanta University
Menoufia University

Investigators

Principal Investigator: Eman Ghonaim, Assistant Lecturer, Faculty of Pharmacy, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Ghonaim, Assistant lecturer, Tanta University

ClinicalTrials.gov Identifier:

NCT06010992

Other Study ID Numbers:

36264MD53/3/23

First Posted:

Aug 25, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Nitazoxanide

Study Results

No Results Posted as of Aug 25, 2023