Diabetes Mellitus, Type 2Phase 2NCT06010992
Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus
A Phase 2 study testing Nitazoxanide in people with Diabetes Mellitus, Type 2, run by Tanta University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2023to 1 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glycated hemoglobin (HbA1c) between 7% and 9%.
- Body mass index ≥ 25 kg/m2
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Medicine, Menoufia University
Shibīn al Kawm, Menoufia, 32511
Eman Ghonaim, +20-010-970-812-57, eman.ghonim@pharm.tanta.edu.eg
- Recruiting
Faculty of medicine, Tanta University
Tanta, El-Gharbia, 31527
Eman Ghonaim, +20-010-970-821-57, eman.ghonim@pharm.tanta.edu.eg
About this study
Official title: A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Nitazoxanide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Nitazoxanide oral capsules 500 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Nitazoxanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Fasting blood glucose and glycated hemoglobin
Measured: 12 weeks
Secondary outcomes (4)
Insulin resistance
fasting insulin level with HOMA-IR calculation
Measured: 12 weeks
Lipid profile
Serum levels of total cholesterol, LDL, HDL, and triglycerides
Measured: 12 weeks
Serum levels of A-kinase anchoring protein 1
Measured: 12 weeks
Serum levels of asprosin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, Eman Ghonaim, Tanta University
- Investigators
- Eman Ghonaim, Principal investigator, Assistant Lecturer, Faculty of Pharmacy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010992
- Sponsor's protocol ID
- 36264MD53/3/23
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40815384
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Potential Benefit of Nitazoxanide in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06010992
- Acronym / sponsor ID
- 36264MD53/3/23
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Nitazoxanide35 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glycated hemoglobin (HbA1c) between 7% and 9%.
- Body mass index ≥ 25 kg/m2
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideNitazoxanide oral capsules 500 mg twice daily | Drug | Group 2 |
Primary outcome
Glycemic control
Time frame: 12 weeks
Fasting blood glucose and glycated hemoglobin
4 secondary outcomes
Insulin resistance
Time frame: 12 weeks
Lipid profile
Time frame: 12 weeks
Serum levels of A-kinase anchoring protein 1
Time frame: 12 weeks
Serum levels of asprosin
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 40815384Ghonaim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Ghonaim principal investigator
Assistant Lecturer, Faculty of Pharmacy, Tanta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide in people with Diabetes Mellitus, Type 2, run by Tanta University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Ghonaim, Assistant lecturer (+20-010-970-821-57, eman.ghonim@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.