Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06010992

Enrollment

Registered

2023-08-25

Start date

2023-10-01

Completion date

2025-01-01

Last updated

2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGNitazoxanide

Nitazoxanide oral capsules 500 mg twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Glycemic control	12 weeks	Fasting blood glucose and glycated hemoglobin

Secondary

Measure	Time frame	Description
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	—

Countries

Egypt

Contacts

Primary ContactEman Ghonaim, Assistant lecturer

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026