Diabetes Mellitus, Type 2Phase 2NCT06423729
Effect of Nicorandil in Type 2 Diabetic Obese Patients
A Phase 2 study testing Nicorandil 10 MG in people with Diabetes Mellitus, Type 2, run by Tanta University at 1 site in Egypt.
Trial summary
1. Evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas. 2. Investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Nicorandil 10 MG
- 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
- 1 Nov 2023to 30 Nov 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients newly diagnosed with diabetes .
- Body mass index (BMI) >30 Kg/m2.
- The selected patients are treated with sulfonylureas alone.
- The age of selected patient ranged from 18 and 60 years.
Who cannot join
- Pregnant and lactating females.
- Patients with hypersensitivity to nicorandil.
- Uncontrolled hypertension and its antihypertensive medications
- Severe renal or hepatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Effect of Nicorandil in Type 2 Diabetic Obese Patients Treated With Sulfonylurea
- Evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas.
- Investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Nicorandil 10 MG
- Keywords
- Type 2 DM, Nicorandil, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil 10 MGDrug
Patients will receive oral Nicorandil 10 MG twice daily in addition to 2nd generation sulfonylureas , for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | 23 patients who will receive 2nd generation sulfonylureas only, for three months. |
| Nicorandil Arm | Experimental | 23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months. Receives: Drug: Nicorandil 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c level
Change in HbA1c (From baseline to 12 weeks)
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in body weight.
Change in body weight (From baseline to 12 weeks).
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in Body mass index (BMI)
Change in Body mass index (BMI) (From baseline to 12 weeks).
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in Visceral adiposity index (VAI).
Change in Visceral adiposity index (VAI) (From baseline to 12 weeks).
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Secondary outcomes (1)
Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels.
Assessment of Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide levels by ELISA Kits according to manufacturer's instructions.
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Nov 2023
- Primary completion30 Jul 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Mohamed Seddik Ali, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423729
- Sponsor's protocol ID
- Nicorandil in DM
- Status last verified
- Aug 2026
- First submitted
- 16 May 2024
- Last updated
- 12 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Effect of Nicorandil in Type 2 Diabetic Obese Patients Treated With Sulfonylurea
- ClinicalTrials.gov ID
- NCT06423729
- Acronym / sponsor ID
- Nicorandil in DM
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 DM, Nicorandil, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 21 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.
- Evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas.
- Investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –23 patients who will receive 2nd generation sulfonylureas only, for three months. |
| Nicorandil Arm | Experimental | Drug: Nicorandil 10 MG23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients newly diagnosed with diabetes .
- Body mass index (BMI) >30 Kg/m2.
- The selected patients are treated with sulfonylureas alone.
- The age of selected patient ranged from 18 and 60 years.
Key exclusion criteria (4 listed)
- Pregnant and lactating females.
- Patients with hypersensitivity to nicorandil.
- Uncontrolled hypertension and its antihypertensive medications
- Severe renal or hepatic disease.
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 MGPatients will receive oral Nicorandil 10 MG twice daily in addition to 2nd generation sulfonylureas , for 3 months. | Drug | Nicorandil Arm |
Primary outcome
Change in HbA1c level
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in HbA1c (From baseline to 12 weeks)
Change in body weight.
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in body weight (From baseline to 12 weeks).
Change in Body mass index (BMI)
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in Body mass index (BMI) (From baseline to 12 weeks).
Change in Visceral adiposity index (VAI).
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in Visceral adiposity index (VAI) (From baseline to 12 weeks).
1 secondary outcome
Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels.
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Nicorandil 10 MG in people with Diabetes Mellitus, Type 2, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 12 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c level (time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.). The study lists 4 primary outcomes in all. 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 12 Aug 2026.