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RecruitingNCT07794475Updated Aug 31, 2026

Effect of Trimetazidine on Endothelin-1 and Clinical Outcomes of Patients With Diabetic Peripheral Neuropathy

A Phase 1/2 interventional study of Trimetazidine Dihydrochloride Tablets in Diabetic Peripheral Neuropathic Pain (DPN), sponsored by Sara Refaat Azab Metry. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Sara Refaat Azab Metry · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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?

Participants in the interventional arm will receive trimetazidine tablets 35 mg twice daily for three months.

02

Conditions studied

  • Diabetic Peripheral Neuropathic Pain (DPN)
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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%

Exclusion criteria

Exclusion criteria:

  • 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.
  • 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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    trimetazidine

    Drug: Trimetazidine Dihydrochloride Tablets

  • No intervention
    control

Interventions

  • DrugTrimetazidine Dihydrochloride Tablets

    trimetazidine 35 mg oral tablets twice daily

05

What researchers measure

Primary outcomes

  1. Endothelin-1 levels

    Time frame: at baseline assessment and at 12 weeks

Secondary outcomes

  1. DN4 score (neuropathic pain scale).

    Time frame: at baseline assessment and at 12 weeks

  2. Toronto clinical scoring systems for assessing the peripheral diabetic neuropathy severity

    Time frame: at baseline assessment and at 12 weeks

  3. Numeric rating scale for pain assessment

    Time frame: at baseline assessment and at 12 weeks

  4. side effects

    Time frame: every 4 weeks and at the end of the study at 12 weeks.

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07794475
Lead sponsor
Sara Refaat Azab Metry
Responsible party
Sara Refaat Azab Metry (Lecturer, Ain Shams University) — Sponsor-investigator
First posted
Aug 31, 2026
Start date
Aug 1, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Aug 31, 2026

Study contacts

Lamia El Wakeel, PhD
principal investigator · Faculty of Pharmacy, Ain Shams University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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