Diabetic Peripheral Neuropathic Pain (DPN)Phase 1/2NCT07794475
Effect of Trimetazidine on Endothelin-1 and Clinical Outcomes of Patients With Diabetic Peripheral Neuropathy
A Phase 1/2 study testing Trimetazidine Dihydrochloride Tablets in people with Diabetic Peripheral Neuropathic Pain (DPN), run by Sara Refaat Azab Metry at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate if trimetazidine can improve clinical outcomes of patients with diabetic peripheral neuropathy. The main questions it aims to answer are: Does trimetazidine improve the symptoms of diabetic peripheral neuropathy? Does trimetazidine affect endothelin-1 levels?… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain (DPN)
- What is being tested?
- Trimetazidine Dihydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18-65 years diagnosed with Type 2 Diabetes.
- Regular attendance of the outpatient diabetes clinic of national institute of diabetes to ensure adequate follow up, glycemic control and monitor any complication or side effect.
- Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test).
- Glycated Hgb more than 7%
Who cannot join
- Patients with autoimmune disorders (Sjogren's syndrome, lupus, rheumatoid arthritis), inherited disorders causing peripheral neuropathy, thyroid diseases, chronic inflammatory demyelinating polyneuropathy, patients undergoing gastroplasty surgery, and cancer patients.
- Patients have Parkinson disease or any motor movement disorders
- Any clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or other endocrine disease.
- Pressure on or injury to the nerves
- Patients with kidney (eGFR less than 30 ml/min) or severe liver dysfunction (ALT more than 3x ULN).
- Patients with recent history of infection.
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- Patients with cerebral vascular disease, vasculitis, toxic neuritis, spondyloarthropathy, foot edema or ulcer and diagnosis of other neuromuscular disorders or neurodegenerative diseases.
- Use of medications or supplements known to cause peripheral neuropathy.
- Patients consuming alcohol, any antioxidant supplements or anti-inflammatory medicines and drug abuse.
- Ketoacidosis or hypoglycemia resulting in hospital admission within the last 3 months.
- Pregnancy or lactation.
- Medical, psychological, behavioral or pharmacological factors interfering with the ability to participate in a trial.
- Any known allergy to Trimetazidine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Institute of Diabetes
Cairo
Sara R A Metry, +201061743901, sara_azab@pharma.asu.edu.eg
About this study
The goal of this clinical trial is to investigate if trimetazidine can improve clinical outcomes of patients with diabetic peripheral neuropathy. The main questions it aims to answer are:
Does trimetazidine improve the symptoms of diabetic peripheral neuropathy? Does trimetazidine affect endothelin-1 levels?
Participants in the interventional arm will receive trimetazidine tablets 35 mg twice daily for three months.
- Being tested
- Trimetazidine Dihydrochloride Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimetazidine Dihydrochloride TabletsDrug
trimetazidine 35 mg oral tablets twice daily
| Study group | Role | What they receive |
|---|---|---|
| trimetazidine | Experimental | Not described Receives: Drug: Trimetazidine Dihydrochloride Tablets |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelin-1 levels
Measured: at baseline assessment and at 12 weeks
Secondary outcomes (4)
DN4 score (neuropathic pain scale).
Measured: at baseline assessment and at 12 weeks
Toronto clinical scoring systems for assessing the peripheral diabetic neuropathy severity
Measured: at baseline assessment and at 12 weeks
Numeric rating scale for pain assessment
Measured: at baseline assessment and at 12 weeks
side effects
Measured: every 4 weeks and at the end of the study at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic Pain (DPN)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sara Refaat Azab Metry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Refaat Azab Metry, Ain Shams University
- Investigators
- Lamia El Wakeel, PhD, Principal investigator, Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794475
- Sponsor's protocol ID
- ACUC-FP-ASU-REC#435
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trimetazidine on Endothelin-1 and Clinical Outcomes of Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07794475
- Acronym / sponsor ID
- ACUC-FP-ASU-REC#435
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sara Refaat Azab MetryUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 31 Aug 2026 (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.
The goal of this clinical trial is to investigate if trimetazidine can improve clinical outcomes of patients with diabetic peripheral neuropathy. The main questions it aims to answer are:
Does trimetazidine improve the symptoms of diabetic peripheral neuropathy? Does trimetazidine affect endothelin-1 levels?
Participants in the interventional arm will receive trimetazidine tablets 35 mg twice daily for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trimetazidine | Experimental | Drug: Trimetazidine Dihydrochloride Tablets |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females aged 18-65 years diagnosed with Type 2 Diabetes.
- Regular attendance of the outpatient diabetes clinic of national institute of diabetes to ensure adequate follow up, glycemic control and monitor any complication or side effect.
- Patients diagnosed with Diabetic Neuropathy (by pinprick, temperature, ankle reflex, and vibration perception (128-Hz tuning fork) or pressure sensation (10 g monofilament test).
- Glycated Hgb more than 7%
Key exclusion criteria (13 listed)
- Patients with autoimmune disorders (Sjogren's syndrome, lupus, rheumatoid arthritis), inherited disorders causing peripheral neuropathy, thyroid diseases, chronic inflammatory demyelinating polyneuropathy, patients undergoing gastroplasty surgery, and cancer patients.
- Patients have Parkinson disease or any motor movement disorders
- Any clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or other endocrine disease.
- Pressure on or injury to the nerves
- Patients with kidney (eGFR less than 30 ml/min) or severe liver dysfunction (ALT more than 3x ULN).
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 |
|---|---|---|
| Trimetazidine Dihydrochloride Tabletstrimetazidine 35 mg oral tablets twice daily | Drug | trimetazidine |
Primary outcome
Endothelin-1 levels
Time frame: at baseline assessment and at 12 weeks
4 secondary outcomes
DN4 score (neuropathic pain scale).
Time frame: at baseline assessment and at 12 weeks
Toronto clinical scoring systems for assessing the peripheral diabetic neuropathy severity
Time frame: at baseline assessment and at 12 weeks
Numeric rating scale for pain assessment
Time frame: at baseline assessment and at 12 weeks
side effects
Time frame: every 4 weeks and at the end of the study at 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- 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.
Lamia El Wakeel, PhD principal investigator
Faculty of Pharmacy, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Trimetazidine Dihydrochloride Tablets in people with Diabetic Peripheral Neuropathic Pain (DPN), run by Sara Refaat Azab Metry at 1 site 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelin-1 levels (time frame: at baseline assessment and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.