Diabetes Mellitus, Type 2Phase 2NCT05556005
Efficacy of Trimetazidine in Diabetic Patients
A Phase 2 study testing Trimetazidine Dihydrochloride in people with Diabetes Mellitus, Type 2 and Diabetic Cardiomyopathies, run by Ain Shams University at 1 site in Egypt.
Trial summary
Subclinical diastolic dysfunction represents the early phase of diabetic cardiomyopathy and is a common complication among type 2 diabetic patients that increases mortality rate among those patients and can progress to heart failure with preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies
- What is being tested?
- Trimetazidine Dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Sep 2022to Sep 2023
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 40-75 years
- Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50%
Who cannot join
- Patients with valvular, congenital or ischemic heart disease.
- Patients with inadequately controlled hypertension (blood pressure>140/90 mm Hg)
- Patients with HbA1c% <10 %
- Patients with history of intolerance or allergic response to TMZ
- Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance < 30 ml/min)
- Patients with other significant comorbidities such as malignancy, significant psychiatric illness, autoimmune diseases.
- Patients with Parkinson's disease or motor disorders
- Pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams university hospitals
Cairo
lamia El wakeel, Professor, Lamia.elwakeel@pharma.asu.edu.eg
About this study
Official title: Effect Of Trimetazidine On Left Ventricular Functions and Inflammatory Markers of Patients With Type 2 Diabetes Mellitus
Subclinical diastolic dysfunction represents the early phase of diabetic cardiomyopathy and is a common complication among type 2 diabetic patients that increases mortality rate among those patients and can progress to heart failure with preserved ejection fraction. Trimetazidine is an anti-ischemic agent widely used in the treatment of coronary artery disease and it has positive effects on energy metabolism in heart failure.
Therefore, we hypothesized that trimetazidine may have potential benefit on the amelioration of the inflammatory insult and improving the clinical outcomes in patients with diabetic cardiomyopathy especially if applied in the early stages.
- Being tested
- Trimetazidine Dihydrochloride, Placebo
- Keywords
- Trimetazidine, Diastolic dysfunction, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimetazidine DihydrochlorideDrug
Also called Vasteral mr
Trimetazidine Dihydrochloride 35 mg modified release tablet used twice daily
PlaceboDrug
Starch tablets used twice daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months. Receives: Drug: Trimetazidine Dihydrochloride |
| Group 2 | Placebo comparator | Patients will receive Placebo tablet twice daily in addition to their standard treatment for three months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Left ventricular functions at 3 months
assessed using echocardiographic and tissue doppler evaluation
Measured: at baseline and after three months of intervention
Secondary outcomes (2)
Change from baseline Tumor necrosis factor alpha at 3 months
assessed using ELISA technique
Measured: at baseline and after three months of intervention
Change from baseline Transforming growth factor beta 1 at 3 months
assessed using ELISA technique
Measured: at baseline and after three months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start18 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (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 Ain Shams 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba ibrahim Mohamed serag, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556005
- Sponsor's protocol ID
- RHDIRB2020110301
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Serag H, Wakeel LE, William V, Abdelsalam M, Abdelsalam A, Sayed R. Effect of trimetazidine on left ventricular functions and cardiac biomarkers in diabetic patients with left ventricular diastolic dysfunction: a randomized controlled trial. Sci Rep. 2025 Jan 16;15(1):2115. doi: 10.1038/s41598-024-83213-w.
PubMed 39814796
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Trimetazidine On Left Ventricular Functions and Inflammatory Markers of Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05556005
- Acronym / sponsor ID
- RHDIRB2020110301
- Keywords
- Trimetazidine, Diastolic dysfunction, diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 27 Sep 2022 (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.
Subclinical diastolic dysfunction represents the early phase of diabetic cardiomyopathy and is a common complication among type 2 diabetic patients that increases mortality rate among those patients and can progress to heart failure with preserved ejection fraction. Trimetazidine is an anti-ischemic agent widely used in the treatment of coronary artery disease and it has positive effects on energy metabolism in heart failure.
Therefore, we hypothesized that trimetazidine may have potential benefit on the amelioration of the inflammatory insult and improving the clinical outcomes in patients with diabetic cardiomyopathy especially if applied in the early stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Trimetazidine DihydrochloridePatients will receive 35 mg of Trimetazidine modified release tablet twice daily in addition to their standard treatment for three months. |
| Group 2 | Placebo comparator | Drug: PlaceboPatients will receive Placebo tablet twice daily in addition to their standard treatment for three months. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age from 40-75 years
- Patients with echocardiographic evidence of grade I or II diastolic dysfunction with LVEF ≥50%
Key exclusion criteria (8 listed)
- Patients with valvular, congenital or ischemic heart disease.
- Patients with inadequately controlled hypertension (blood pressure>140/90 mm Hg)
- Patients with HbA1c% <10 %
- Patients with history of intolerance or allergic response to TMZ
- Patients with severe liver dysfunction or severe renal dysfunction (creatinine clearance < 30 ml/min)
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 DihydrochlorideAlso: Vasteral mrTrimetazidine Dihydrochloride 35 mg modified release tablet used twice daily | Drug | Group 1 |
| PlaceboStarch tablets used twice daily | Drug | Group 2 |
Primary outcome
Change from baseline Left ventricular functions at 3 months
Time frame: at baseline and after three months of intervention
assessed using echocardiographic and tissue doppler evaluation
2 secondary outcomes
Change from baseline Tumor necrosis factor alpha at 3 months
Time frame: at baseline and after three months of intervention
Change from baseline Transforming growth factor beta 1 at 3 months
Time frame: at baseline and after three months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 39814796Serag H, Wakeel LE, William V, Abdelsalam M, Abdelsalam A, Sayed R. Effect of trimetazidine on left ventricular functions and cardiac biomarkers in diabetic patients with left ventricular diastolic dysfunction: a randomized controlled trial. Sci Rep. 2025 Jan 16;15(1):2115. doi: 10.1038/s41598-024-83213-w.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimetazidine Dihydrochloride in people with Diabetes Mellitus, Type 2 and Diabetic Cardiomyopathies, run by Ain Shams University 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 2 inclusion and 8 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 27 Sep 2022. 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. Some participants in this study may receive a placebo. 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 heba I serag, Master (01008344689 ext. 002, hebaibrahim92@pharm.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Left ventricular functions at 3 months (time frame: at baseline and after three months of intervention). 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 NCT05556005, 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 27 Sep 2022.