DiabeticPhase 4NCT07083232
The Effect of Sitagliptin, Pioglitazone and Dapagliflozine on Myocardial Infarction in Diabetic Rats
A Phase 4 study testing standard normal diet, low dose Streptozotocin and Sitagliptin (Novartis, USA) in people with Diabetic and Myocardial Infarction, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Diabetic, Myocardial Infarction
- What is being tested?
- standard normal diet, low dose Streptozotocin and Sitagliptin (Novartis, USA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2024to 30 Nov 2024
- Phase
- Phase 4
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 50 adult male albino rats obtained from (Experimental Animal Breeding Farm, assuit -Cairo) weighing between 150- 200 g (at the beginning of the study)
Who cannot join
- Female rats --Weight >200g
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Effect of Sitagliptin, Pioglitazone and Dapagliflozine on Myocardial Infarction Induced Experimentally in Diabetic Rats
The aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats.
Read the detailed description
The American Diabetes Association defined diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction and failure of different organs, especially the eyes, kidneys, nerves, heart and blood vessels.
Myocardial ischemia represents a condition of sufferance for cardiomyocytes due to coronary blood flow reduction as compared to their metabolic needs, and it may exhibit through several clinical conditions.
People with type 2 diabetes mellitus are at increased risk of cardiovascular disease, heart failure and death, as compared with the general population. Studies show that the excess risks associated with diabetes mellitus are mediated primarily by hyperglycemia and overall poor risk factor control. Effective treatment of traditional cardiovascular risk factors has reduced the excess risk of atherosclerotic cardiovascular disease , such as acute myocardial infarction and stroke in people with type 2 diabetes mellitus.
In the last two decades, several studies have demonstrated reductions in the risk of cardiovascular outcomes and mortality in patients with type 2 diabetes mellitus with improved glucose and cholesterol-lowering therapies. Nevertheless, macrovascular disease remains the most common cause of death in type 2 diabetes mellitus patients and new diabetes therapies are highly desired, especially if they can offer cardiovascular benefits.
Sitagliptin is a potent and highly selective dipeptidyl peptidase-4 competitive inhibitor that does not affect the closely related enzymes dipeptidyl peptidase-8 or dipeptidyl peptidase-9 at therapeutic concentrations.
Sitagliptin found to enhance circulating glucagon-like peptide-1 levels through inhibition of dipeptidyl peptidase -IV activity.
which, in turn, provides cardiovascular protection probably through the anti-inflammatory and anti-atherosclerotic activities of glucagon-like peptide-1. Reduces blood glucose levels, in either the postprandial or the fasting state.
Multiple studies have suggested that pioglitazone, a peroxisome proliferatoractivated receptor γ agonist, used as an insulin-sensitizing agent in the treatment of type 2 diabetes mellitus , may have anti-atherosclerotic effects.
The mechanism of action of dapagliflozine influences a number of cardiovascular disease risk factors, in particular, decreasing blood pressure, reducing body weight (predominantly through reductions in total body fat mass, including visceral adipose tissue), reducing waist circumference, and lowering albuminuria and serum uric acid levels, with allow intrinsic risk of hypoglycemia.
Isoprenaline is a potent β-adrenergic agonist, increases the myocardial oxygen demand by mixture of its positive inotropic and chronotropic actions. Administration of isoprenaline in high doses to animals produces infarct like lesions in the heart similar to those present in myocardial infatction in humans.
The aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats.
- Conditions
- Diabetic, Myocardial Infarction
- Being tested
- standard normal diet, low dose Streptozotocin, Sitagliptin (Novartis, USA), Pioglitazone hydrochloride (Unipharma., Egypt), Dapagliflozine hemihydrate (Janssen, USA)
- Keywords
- Myocardial Infarction, Diabetic, Rats, Sitagliptin, Pioglitazone, Dapagliflozine
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard normal dietDietary supplement
Group I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs
low dose StreptozotocinDrug
Non-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.), was done
Sitagliptin (Novartis, USA)Drug
Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks
Pioglitazone hydrochloride (Unipharma., Egypt)Drug
Pioglitazone treated diabetic group (G4); Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks
Dapagliflozine hemihydrate (Janssen, USA)Drug
Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| standard normal diet and water group | Placebo comparator | Group I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs. Receives: Dietary Supplement: standard normal diet |
| low dose Streptozotocin group | Experimental | Group II: Non-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.) Receives: Drug: low dose Streptozotocin |
| Sitagliptin group | Experimental | Group III: Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks Receives: Drug: Sitagliptin (Novartis, USA) |
| Pioglitazone group | Experimental | Group IV : Pioglitazone treated diabetic group ; Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks Receives: Drug: Pioglitazone hydrochloride (Unipharma., Egypt) |
| Dapagliflozine group | Experimental | Group V : Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks Receives: Drug: Dapagliflozine hemihydrate (Janssen, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
Measured: one week
Secondary outcomes (1)
tumor necrosis factor-α
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start30 Oct 2024
- Primary completion30 Oct 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 DiabeticStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El Shazly Abdelaal Mohaseb, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083232
- Sponsor's protocol ID
- MD/AZ.AST./PHA006/8/231/5/2024
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Effect of Sitagliptin, Pioglitazone and Dapagliflozine on Myocardial Infarction Induced Experimentally in Diabetic Rats
- ClinicalTrials.gov ID
- NCT07083232
- Acronym / sponsor ID
- MD/AZ.AST./PHA006/8/231/5/2024
- Conditions
- Diabetic, Myocardial Infarction
- Keywords
- Myocardial Infarction, Diabetic, Rats, Sitagliptin, Pioglitazone, Dapagliflozine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 24 Jul 2025 (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 aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats.
Detailed description
The American Diabetes Association defined diabetes mellitus as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction and failure of different organs, especially the eyes, kidneys, nerves, heart and blood vessels.
Myocardial ischemia represents a condition of sufferance for cardiomyocytes due to coronary blood flow reduction as compared to their metabolic needs, and it may exhibit through several clinical conditions.
People with type 2 diabetes mellitus are at increased risk of cardiovascular disease, heart failure and death, as compared with the general population. Studies show that the excess risks associated with diabetes mellitus are mediated primarily by hyperglycemia and overall poor risk factor control. Effective treatment of traditional cardiovascular risk factors has reduced the excess risk of atherosclerotic cardiovascular disease , such as acute myocardial infarction and stroke in people with type 2 diabetes mellitus.
In the last two decades, several studies have demonstrated reductions in the risk of cardiovascular outcomes and mortality in patients with type 2 diabetes mellitus with improved glucose and cholesterol-lowering therapies. Nevertheless, macrovascular disease remains the most common cause of death in type 2 diabetes mellitus patients and new diabetes therapies are highly desired, especially if they can offer cardiovascular benefits.
Sitagliptin is a potent and highly selective dipeptidyl peptidase-4 competitive inhibitor that does not affect the closely related enzymes dipeptidyl peptidase-8 or dipeptidyl peptidase-9 at therapeutic concentrations.
Sitagliptin found to enhance circulating glucagon-like peptide-1 levels through inhibition of dipeptidyl peptidase -IV activity.
which, in turn, provides cardiovascular protection probably through the anti-inflammatory and anti-atherosclerotic activities of glucagon-like peptide-1. Reduces blood glucose levels, in either the postprandial or the fasting state.
Multiple studies have suggested that pioglitazone, a peroxisome proliferatoractivated receptor γ agonist, used as an insulin-sensitizing agent in the treatment of type 2 diabetes mellitus , may have anti-atherosclerotic effects.
The mechanism of action of dapagliflozine influences a number of cardiovascular disease risk factors, in particular, decreasing blood pressure, reducing body weight (predominantly through reductions in total body fat mass, including visceral adipose tissue), reducing waist circumference, and lowering albuminuria and serum uric acid levels, with allow intrinsic risk of hypoglycemia.
Isoprenaline is a potent β-adrenergic agonist, increases the myocardial oxygen demand by mixture of its positive inotropic and chronotropic actions. Administration of isoprenaline in high doses to animals produces infarct like lesions in the heart similar to those present in myocardial infatction in humans.
The aim of the present study is to evaluate the prophylactic effect of Sitagliptin, Pioglitazone and Dapagliflozine on Isoprenaline induced myocardial infarction in type II diabetic rats.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| standard normal diet and water group | Placebo comparator | Dietary Supplement: standard normal dietGroup I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs. |
| low dose Streptozotocin group | Experimental | Drug: low dose StreptozotocinGroup II: Non-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.) |
| Sitagliptin group | Experimental | Drug: Sitagliptin (Novartis, USA)Group III: Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks |
| Pioglitazone group | Experimental | Drug: Pioglitazone hydrochloride (Unipharma., Egypt)Group IV : Pioglitazone treated diabetic group ; Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks |
| Dapagliflozine group | Experimental | Drug: Dapagliflozine hemihydrate (Janssen, USA)Group V : Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 50 adult male albino rats obtained from (Experimental Animal Breeding Farm, assuit -Cairo) weighing between 150- 200 g (at the beginning of the study)
Key exclusion criteria (1 listed)
- Female rats --Weight >200g
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 |
|---|---|---|
| standard normal dietGroup I: formed of normal animals. They were allowed standard normal diet and water. They received no drugs | Dietary supplement | standard normal diet and water group |
| low dose StreptozotocinNon-treated diabetic rats; diabetes was induced by administration of 20% fructose solution in drinking water for 2 weeks, then intra peritoneal injection of a low dose STZ (40 mg/kg b.w.), was done | Drug | low dose Streptozotocin group |
| Sitagliptin (Novartis, USA)Sitagliptin treated diabetic group sitagliptin was administered by gastric gavage in a dose 10mg/ kg /day for 4 weeks | Drug | Sitagliptin group |
| Pioglitazone hydrochloride (Unipharma., Egypt)Pioglitazone treated diabetic group (G4); Pioglitazone was administered by gastric gavage in a dose 10 mg/ kg /day for 4 weeks | Drug | Pioglitazone group |
| Dapagliflozine hemihydrate (Janssen, USA)Dapagliflozine treated diabetic group (G5); Dapagliflozine was administered by gastric gavage in a dose 1mg/ kg /day for 4 weeks | Drug | Dapagliflozine group |
Primary outcome
blood glucose
Time frame: one week
1 secondary outcome
tumor necrosis factor-α
Time frame: One week
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 14 Aug 2025.
- Individual participant dataSharing planned: Yes
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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 4 study testing standard normal diet, low dose Streptozotocin and Sitagliptin (Novartis, USA) in people with Diabetic and Myocardial Infarction, run by Al-Azhar 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 1 inclusion and 1 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 14 Aug 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
blood glucose (time frame: one week). 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 14 Aug 2025.