Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Nitazoxanide

Study type: Interventional

Funder types: Other

Identifiers

NCT06010992

36264MD53/3/23

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group 1

No Intervention group

Description:

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

Group 2

Experimental group

Description:

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).

Treatment:

Drug: Nitazoxanide