Type2 Diabetes MellitusPhase 3NCT06430125
Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus
A Phase 3 study testing Nicorandil 10 MG Oral Tablet in people with Type2 Diabetes Mellitus, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Nicorandil 10 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2023to Feb 2025
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C< 7 )
- Age range between 18 and 60 years old.
- Both sexes.
- Stage 1and Stage 2 CKD according to KDIGO .
- Controlled HTN .
Who cannot join
- Pregnant and lactating females.
- Patients with hypersensitivity to nicorandil.
- Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) .
- Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications .
- Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, EL Gharbia
Mohammed A El-hazzab, 201151998914, mohamed150556@pharm.tanta.edu.eg
About this study
Official title: Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus
This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Nicorandil 10 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil 10 MG Oral TabletDrug
Nicorandil 10 MG oral tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | this group will include 23 patients who will receive metformin 2gm/day. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be up titrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks . |
| Nicorandil group | Active comparator | this group will include 23 patients who will receive a combination of metformin 2g/day and nicorandil 10 mg twice daily. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be uptitrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks . Receives: Drug: Nicorandil 10 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of progression of kidney disease as measured by KDIGO.
Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks
Measured: 12 weeks
Secondary outcomes (3)
change in the serum concentrations of Kidney injury molecule 1(Kim-1).
Venous blood will be collected before treatment and after 12 week .
Measured: 12 weeks
change in the serum concentrations of Interleukin 18 (IL-18).
Venous blood will be collected before treatment and after 12 week .
Measured: 12 weeks
change in the serum concentrations of Nitric oxide (NO).
Venous blood will be collected before treatment and after 12 week .
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 posted28 May 2024
- Study start28 Feb 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Atta Ali El-Hazzab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430125
- Sponsor's protocol ID
- Nicorandil Nephroprotective
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06430125
- Acronym / sponsor ID
- Nicorandil Nephroprotective
- Conditions
- Type2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 28 May 2024 (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.
This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –this group will include 23 patients who will receive metformin 2gm/day. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be up titrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks . |
| Nicorandil group | Active comparator | Drug: Nicorandil 10 MG Oral Tabletthis group will include 23 patients who will receive a combination of metformin 2g/day and nicorandil 10 mg twice daily. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be uptitrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C< 7 )
- Age range between 18 and 60 years old.
- Both sexes.
- Stage 1and Stage 2 CKD according to KDIGO .
- Controlled HTN .
Key exclusion criteria (5 listed)
- Pregnant and lactating females.
- Patients with hypersensitivity to nicorandil.
- Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) .
- Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications .
- Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
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 |
|---|---|---|
| Nicorandil 10 MG Oral TabletNicorandil 10 MG oral tablet twice daily | Drug | Nicorandil group |
Primary outcome
prevention of progression of kidney disease as measured by KDIGO.
Time frame: 12 weeks
Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks
3 secondary outcomes
change in the serum concentrations of Kidney injury molecule 1(Kim-1).
Time frame: 12 weeks
change in the serum concentrations of Interleukin 18 (IL-18).
Time frame: 12 weeks
change in the serum concentrations of Nitric oxide (NO).
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 28 May 2024.
Related trials for Type2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 3 study testing Nicorandil 10 MG Oral Tablet in people with Type2 Diabetes Mellitus, run by Tanta 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 5 inclusion and 5 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 28 May 2024. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mohammed A El-hazzab (201151998914, mohamed150556@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of progression of kidney disease as measured by KDIGO. (time frame: 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 28 May 2024.