Type2 Diabetes MellitusPhase 3DapaHeartNCT03313752
Effects of SGLT2 Inhibition on Myocardial Insulin Sensitivity
A Phase 3 study testing Dapagliflozin 10Mg Tab in people with Type2 Diabetes Mellitus and Stable Coronary Artery Disease, run by Giaccari Andrea at 1 site in Italy.
Trial summary
A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind, placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week double-blind, placebo-controlled treatment phase and a 4-week follow-up phase. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type2 Diabetes Mellitus, Stable Coronary Artery Disease
- What is being tested?
- Dapagliflozin 10Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2017to 6 Oct 2022
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study-specific procedures
- Female or male subjects aged between 40 and 75 inclusive. Patients who have been surgically sterilized (hysterectomy or tubal-ligation) at least 12 months prior to screening, or are postmenopausal having had no regular menstrual bleeding for at least one (1) year prior to screening. Menopause will be confirmed by a plasma follicle stimulating hormone (FSH) level of > 35 IU/mL at screening, or Women with childbearing potential willing not to initiate pregnancy during the course of the study, and non-nursing women.
- Men having relationships with women with childbearing potential willing not to procure a pregnancy during the course of the study;
- Patients with type 2 diabetes
- Patients with established, stable CAD, defined as ≥30% coronary stenosis in at least one major coronary vessel on invasive coronary angiography (ICA) or computed tomography angiography (CTA) performed within 12 months from screening and no indication to revascularization or with no evidence of critical restenosis, if previously subjected to percutaneous coronary intervention (PCI) (>6months).
- Patients with a clinical indication for 13N-ammonia PET-CT, as established by a cardiologist, nuclear medicine physician or diabetologist.
Show all 11Show fewer
- Patients with a body mass index (BMI) equal or greater than 25 kg/m2 but less than 35 kg/m2 [BMI = Weight (kg) / Height squared (m2)]
- Patients with a HbA1c between 7.0% and 8.5%, according to the actual clinical conditions of the patients;
- Patients with diabetes duration <10 years;
- Patients with stable medical therapy [including other anti-hyperglycemic agents (see Table 1, section 5.2.1 for all therapies allowed, as per current standard treatment); pioglitazone and basal-bolus insulin treatment are excluded, as reported in the exclusion criteria 15] for at least 3 months prior to the screening visit (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months.
- Patients with Fasting C-peptide > 1 ng/mL (0.33 nmol/L) at Visit 0
Who cannot join
- Type 1 diabetes (as assessed by medical history); previous diagnosis of Latent Autoimmune Diabetes of Adults (LADA), and or not fulfilling inclusion criteria #10
- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- NYHA class III or IV
- Unstable angina
- Previous re-vascularisation (either percutaneous coronary intervention or coronary artery bypass graft) in the last <6 months before screening
- Reduced left ventricular ejection fraction (≤ 50%)
Show all 23Show fewer
- Increased likelihood of developing diabetic ketoacidosis (history of DKA, alcohol consumption, volume depletion dehydration, clinical conditions causing diarrhea, vomit and anorexia)
- Moderate to severe renal impairment (eGFR<60 ml/min/1.73m2 as calculated by the modification of diet in renal disease [MDRD] equation or end-stage renal disease); overt proteinuria, defined as Spot urine Microalbumin/Cr ratio of >300 mg/g at screening (Visit 0)
- Severe liver dysfunction
- Asthma
- Uncontrolled blood pressure
- Symptomatic tachy- or bradyarrhythmias
- Previous acute myocardial infarction
- Contraindications to adenosine: known hypersensitivity to adenosine or to any of the excipients; sick sinus syndrome, second or third degree atrio-ventricular block (except in patients with a functioning artificial pacemaker); chronic obstructive lung disease with evidence of bronchospasm (e.g. bronchial asthma ); long QT syndrome; severe hypotension; decompensated states of heart failure
- Use of pioglitazone; use of loop diuretics; basal-bolus insulin therapy; use of systemic steroids less than 3 days prior to the screening visit (Visit 0)
- Known hypersensitivity to the active substance or to any of the excipients in study drug
- Inability to provide informed consent
- Participation in another clinical study with an investigational product during the previous 30 days
- Patients with history of breast, bladder and prostate cancer
- Patients who will undergo surgical procedures
- Patients with acute urinary tract infection
- Patients with history of intolerance to galactose and lactose
- Severe/uncontrolled medical conditions, causing liquid volume depletion
Trial locations and contacts
1 site in 1 country.
Italy1 site
Center For Endocrine and Metabolic Diseases - Catholic University
Rome, RM, 00168
About this study
Official title: Study on the Effect of Dapagliflozin on Myocardial Insulin Sensitivity and Perfusion
A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind, placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week double-blind, placebo-controlled treatment phase and a 4-week follow-up phase.
Subjects: Type 2 diabetic patients and coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable at time of screening visit, with suboptimal glycaemic control (HbA1c 7.0-8.5%) on their current anti-hyperglycaemic regimen
Read more
Subjects will be randomized in a 1:1 ratio to dapagliflozin or placebo.
Subjects will undergo screening assessment in the 14-day period preceding administration of the first dose of study drug on Day 1.
The primary Objective is to assess the effect of dapagliflozin on myocardial insulin sensitivity The Secondary Objective is to assess global heart function, and metabolic systemic effects of dapagliflozin, and glycemic control.
The study aims to enroll patients with type 2 diabetes with suboptimal glycemic control, and with coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable, who have already undergone, under routine cardiological assessment, a positron emission tomography (PET) 13NH3 scan in order to assess the cardiovascular function. Thus, the study aims to assess whether the improvement in cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal clinical practice (according to Standards of Care).
Read the detailed description
This Phase III, single-centre, randomized, double-blind, placebo-controlled study is designed to evaluate the impact of dapagliflozin on myocardial insulin sensitivity, global cardiac function, metabolic effects, and glycemic control in patients with type 2 diabetes (T2D) and stable coronary artery disease (CAD). The study consists of three phases: a 14-day screening phase (Days -14 to -1), a 4-week double-blind treatment phase, and a 4-week follow-up phase.
Patients eligible for this study must have suboptimal glycemic control (HbA1c 7.0-8.5%) on a stable anti-hyperglycemic regimen and meet specific inclusion criteria, including a history of stable CAD with ≥30% coronary stenosis or prior percutaneous coronary intervention (PCI) performed at least six months prior to screening, without an indication for revascularization. These patients should have undergone a routine 13N-ammonia PET-CT scan to assess cardiovascular function before enrollment.
During the study, participants are randomized in a 1:1 ratio to receive either 10 mg dapagliflozin or a placebo tablet, administered orally once daily for four weeks. Key assessments include a euglycemic hyperinsulinemic clamp to measure myocardial glucose uptake (MGU) and systemic glucose metabolism. The primary outcome focuses on the change in MGU, reflecting myocardial insulin sensitivity, while secondary outcomes evaluate:
Coronary flow reserve (CFR): Determined as the ratio of myocardial blood flow (MBF) during pharmacological stress to MBF at rest, measured using PET-CT.
Left ventricular function: Assessed at rest and during pharmacological stress via Gated-PET with 13N-ammonia.
Metabolic effects on adipose tissue: Quantitative FDG uptake in pericardial, perirenal, and interscapular fat, measured as SUVmax.
Glycemic control: Changes in fasting glucose concentration and glycated hemoglobin (HbA1c).
Gut microbiota composition: Analyzed at the class, genus, and species levels to assess systemic metabolic effects.
The study aims to enroll patients aged 40-75 years, with a body mass index (BMI) between 25 and 35 kg/m² and a diabetes duration of less than 10 years. Patients with type 1 diabetes, recent myocardial infarction, severe renal or hepatic impairment, or contraindications to study procedures or medications are excluded.
At the end of 4 week-trial, all the patients in the placebo group will start therapy with dapagliflozin.
All the patients will be followed up every 4 years. Coronary flow reserve (CFR): Determined as the ratio of myocardial blood flow (MBF) during pharmacological stress to MBF at rest, measured using PET-CT, will be re-evaluated at the end follow up.
This trial seeks to determine whether the metabolic and cardiac improvements achieved with dapagliflozin are superior to those achieved with standard clinical practice, aligning with current Standards of Care. The results will provide robust evidence on the role of SGLT2 inhibitors in addressing the residual cardiovascular risk in T2D patients.
- Being tested
- Dapagliflozin 10Mg Tab, Placebo
- Keywords
- diabetes, heart, dapagliflozin,
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
Dapagliflozin, will be administered according to the approved posology and to the approved dose as stated by Local Health Indication and by the Drug Brochure
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| A - placebo | Placebo comparator | Green, plain, diamond shaped, film coated tablet (orally), not containing active ingredient; once daily, for 4 weeks Receives: Other: Placebo |
| B - experimental drug | Experimental | Dapagliflozin tablet available at dose of 10 mg, once daily, for 4 weeks Receives: Drug: Dapagliflozin 10Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of dapagliflozin on myocardial insulin sensitivity
Myocardial Glucose Uptake (MGU) umol/min/gr during euglycemic hyperinsulinemic clamp: change from baseline
Measured: 4 weeks
Secondary outcomes (8)
Effect on Coronary flow reserve [Main Secondary Outcome]
Coronary flow reserve (CFR) obtained as ratio of myocardial blood flow (ml/min/g) (MBF) during pharmacological stress and MBF at rest: change from baseline
Measured: 4 weeks
3. Browning of white adipose tissue: change from baseline
Quantitative measurement of FDG uptake in pericardial, perirenal, interscapular fat by total body FDG PET-CT study, expressed as maximum Standard Uptake Volume (SUVmax) (change from baseline)
Measured: 4 weeks
Metabolic systemic effects of dapagliflozin
Whole body glucose uptake calculated as mg/kg/min during the euglycemic hyperinsulinemic clamp: change from baseline
Measured: 4 weeks
Effect on Left Ventricular Ejection Fraction at rest
Whole body glucose uptake calculated as mg/kg/min during the euglycemic hyperinsulinemic clamp: change from baseline
Measured: 4 weeks
Effect on Left Ventricular Ejection Fraction during pharmacological stress
Left Ventricular Ejection Fraction (percent %) measured by Gated-PET with 13N-ammonia during pharmacological stress: change from baseline
Measured: 4 weeks
Fasting glucose concentration change from baseline
Measured as fasting glucose concentration (mg/dl): change from baseline
Measured: 4 weeks
Glycemic control change from baseline
Measured as Glycated hemoglobin (HbA1c) (percent %): change from baseline
Measured: 4 weeks
Gut microbiota composition change from baseline
Analysis of gut microbiota composition at class, genus, and species levels: change from baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Dec 2017
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giaccari Andrea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giaccari Andrea, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Andrea Giaccari, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313752
- Sponsor's protocol ID
- 2016-003614-27
- Other IDs
- 2016
- Acronym
- DapaHeart
- Status last verified
- May 2026
- First submitted
- 4 Oct 2017
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cinti F, Morciano C, Guarneri A, Cappannoli L, Sorice G, Gugliandolo S, Capece U, Splendore A, Avolio A, Mezza T, Iozzo P, Pontecorvi A, Calcagni ML, Burzotta F, D'Amario D, Crea F, Leccisotti L, Giaccari A. Coronary flow reserve increase after 4-year dapagliflozin treatment in patients with type 2 diabetes: the DAPAHEART follow-up study. Cardiovasc Diabetol. 2025 Aug 31;24(1):351. doi: 10.1186/s12933-025-02912-4.
PubMed 40887630Cinti F, Leccisotti L, Sorice GP, Capece U, D'Amario D, Lorusso M, Gugliandolo S, Morciano C, Guarneri A, Guzzardi MA, Mezza T, Capotosti A, Indovina L, Ferraro PM, Iozzo P, Crea F, Giordano A, Giaccari A. Dapagliflozin treatment is associated with a reduction of epicardial adipose tissue thickness and epicardial glucose uptake in human type 2 diabetes. Cardiovasc Diabetol. 2023 Dec 19;22(1):349. doi: 10.1186/s12933-023-02091-0.
PubMed 38115004Capece U, Pavanello C, Cinti F, Leccisotti L, Mezza T, Ciccarelli G, Moffa S, Di Giuseppe G, Soldovieri L, Brunetti M, Giordano A, Giaccari A, Calabresi L, Ossoli A. Dapagliflozin-Induced Myocardial Flow Reserve Improvement is not Associated with HDL Ability to Stimulate Endothelial Nitric Oxide Production. Diabetes Ther. 2024 Jan;15(1):257-268. doi: 10.1007/s13300-023-01491-5. Epub 2023 Oct 26.
PubMed 37883003Leccisotti L, Cinti F, Sorice GP, D'Amario D, Lorusso M, Guzzardi MA, Mezza T, Gugliandolo S, Cocchi C, Capece U, Indovina L, Ferraro PM, Iozzo P, Crea F, Giordano A, Giaccari A. Dapagliflozin improves myocardial flow reserve in patients with type 2 diabetes: the DAPAHEART Trial: a preliminary report. Cardiovasc Diabetol. 2022 Sep 3;21(1):173. doi: 10.1186/s12933-022-01607-4.
PubMed 36057768Sorice GP, Cinti F, Leccisotti L, D'Amario D, Lorusso M, Guzzardi MA, Mezza T, Cocchi C, Capece U, Ferraro PM, Crea F, Giordano A, Iozzo P, Giaccari A. Effect of Dapagliflozin on Myocardial Insulin Sensitivity and Perfusion: Rationale and Design of The DAPAHEART Trial. Diabetes Ther. 2021 Jul;12(7):2101-2113. doi: 10.1007/s13300-021-01083-1. Epub 2021 May 26.
PubMed 34037951
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Dapagliflozin on Myocardial Insulin Sensitivity and Perfusion
- ClinicalTrials.gov ID
- NCT03313752
- Acronym / sponsor ID
- DapaHeart / 2016-003614-27
- Keywords
- diabetes, heart, dapagliflozin,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Giaccari AndreaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 18 Oct 2017 (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.
A Phase III, single-centre, randomized, 2-arm, parallel-group, double blind, placebo-controlled study, consisting of a screening phase (Days -14 to -1), a 4-week double-blind, placebo-controlled treatment phase and a 4-week follow-up phase.
Subjects: Type 2 diabetic patients and coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable at time of screening visit, with suboptimal glycaemic control (HbA1c 7.0-8.5%) on their current anti-hyperglycaemic regimen
Subjects will be randomized in a 1:1 ratio to dapagliflozin or placebo.
Subjects will undergo screening assessment in the 14-day period preceding administration of the first dose of study drug on Day 1.
The primary Objective is to assess the effect of dapagliflozin on myocardial insulin sensitivity The Secondary Objective is to assess global heart function, and metabolic systemic effects of dapagliflozin, and glycemic control.
The study aims to enroll patients with type 2 diabetes with suboptimal glycemic control, and with coronary artery diseases (CAD) not requiring revascularization or underwent percutaneous coronary intervention (PCI) but clinically stable, who have already undergone, under routine cardiological assessment, a positron emission tomography (PET) 13NH3 scan in order to assess the cardiovascular function. Thus, the study aims to assess whether the improvement in cardiac metabolism obtained with dapagliflozin is greater than that obtained with normal clinical practice (according to Standards of Care).
Detailed description
This Phase III, single-centre, randomized, double-blind, placebo-controlled study is designed to evaluate the impact of dapagliflozin on myocardial insulin sensitivity, global cardiac function, metabolic effects, and glycemic control in patients with type 2 diabetes (T2D) and stable coronary artery disease (CAD). The study consists of three phases: a 14-day screening phase (Days -14 to -1), a 4-week double-blind treatment phase, and a 4-week follow-up phase.
Patients eligible for this study must have suboptimal glycemic control (HbA1c 7.0-8.5%) on a stable anti-hyperglycemic regimen and meet specific inclusion criteria, including a history of stable CAD with ≥30% coronary stenosis or prior percutaneous coronary intervention (PCI) performed at least six months prior to screening, without an indication for revascularization. These patients should have undergone a routine 13N-ammonia PET-CT scan to assess cardiovascular function before enrollment.
During the study, participants are randomized in a 1:1 ratio to receive either 10 mg dapagliflozin or a placebo tablet, administered orally once daily for four weeks. Key assessments include a euglycemic hyperinsulinemic clamp to measure myocardial glucose uptake (MGU) and systemic glucose metabolism. The primary outcome focuses on the change in MGU, reflecting myocardial insulin sensitivity, while secondary outcomes evaluate:
Coronary flow reserve (CFR): Determined as the ratio of myocardial blood flow (MBF) during pharmacological stress to MBF at rest, measured using PET-CT.
Left ventricular function: Assessed at rest and during pharmacological stress via Gated-PET with 13N-ammonia.
Metabolic effects on adipose tissue: Quantitative FDG uptake in pericardial, perirenal, and interscapular fat, measured as SUVmax.
Glycemic control: Changes in fasting glucose concentration and glycated hemoglobin (HbA1c).
Gut microbiota composition: Analyzed at the class, genus, and species levels to assess systemic metabolic effects.
The study aims to enroll patients aged 40-75 years, with a body mass index (BMI) between 25 and 35 kg/m² and a diabetes duration of less than 10 years. Patients with type 1 diabetes, recent myocardial infarction, severe renal or hepatic impairment, or contraindications to study procedures or medications are excluded.
At the end of 4 week-trial, all the patients in the placebo group will start therapy with dapagliflozin.
All the patients will be followed up every 4 years. Coronary flow reserve (CFR): Determined as the ratio of myocardial blood flow (MBF) during pharmacological stress to MBF at rest, measured using PET-CT, will be re-evaluated at the end follow up.
This trial seeks to determine whether the metabolic and cardiac improvements achieved with dapagliflozin are superior to those achieved with standard clinical practice, aligning with current Standards of Care. The results will provide robust evidence on the role of SGLT2 inhibitors in addressing the residual cardiovascular risk in T2D patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - placebo | Placebo comparator | Other: PlaceboGreen, plain, diamond shaped, film coated tablet (orally), not containing active ingredient; once daily, for 4 weeks |
| B - experimental drug | Experimental | Drug: Dapagliflozin 10Mg TabDapagliflozin tablet available at dose of 10 mg, once daily, for 4 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of informed consent prior to any study-specific procedures
- Female or male subjects aged between 40 and 75 inclusive. Patients who have been surgically sterilized (hysterectomy or tubal-ligation) at least 12 months prior to screening, or are postmenopausal having had no regular menstrual bleeding for at least one (1) year prior to screening. Menopause will be confirmed by a plasma follicle stimulating hormone (FSH) level of > 35 IU/mL at screening, or Women with childbearing potential willing not to initiate pregnancy during the course of the study, and non-nursing women.
- Men having relationships with women with childbearing potential willing not to procure a pregnancy during the course of the study;
- Patients with type 2 diabetes
- Patients with established, stable CAD, defined as ≥30% coronary stenosis in at least one major coronary vessel on invasive coronary angiography (ICA) or computed tomography angiography (CTA) performed within 12 months from screening and no indication to revascularization or with no evidence of critical restenosis, if previously subjected to percutaneous coronary intervention (PCI) (>6months).
Key exclusion criteria (23 listed)
- Type 1 diabetes (as assessed by medical history); previous diagnosis of Latent Autoimmune Diabetes of Adults (LADA), and or not fulfilling inclusion criteria #10
- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- NYHA class III or IV
- Unstable angina
- Previous re-vascularisation (either percutaneous coronary intervention or coronary artery bypass graft) in the last <6 months before screening
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 |
|---|---|---|
| Dapagliflozin 10Mg TabDapagliflozin, will be administered according to the approved posology and to the approved dose as stated by Local Health Indication and by the Drug Brochure | Drug | B - experimental drug |
| Placeboplacebo | Other | A - placebo |
Primary outcome
Effect of dapagliflozin on myocardial insulin sensitivity
Time frame: 4 weeks
Myocardial Glucose Uptake (MGU) umol/min/gr during euglycemic hyperinsulinemic clamp: change from baseline
8 secondary outcomes
Effect on Coronary flow reserve [Main Secondary Outcome]
Time frame: 4 weeks
3. Browning of white adipose tissue: change from baseline
Time frame: 4 weeks
Metabolic systemic effects of dapagliflozin
Time frame: 4 weeks
Effect on Left Ventricular Ejection Fraction at rest
Time frame: 4 weeks
Effect on Left Ventricular Ejection Fraction during pharmacological stress
Time frame: 4 weeks
Fasting glucose concentration change from baseline
Time frame: 4 weeks
Glycemic control change from baseline
Time frame: 4 weeks
Gut microbiota composition change from baseline
Time frame: 4 weeks
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 8 May 2026.
- Derived from this study: PubMed 40887630Cinti F, Morciano C, Guarneri A, Cappannoli L, Sorice G, Gugliandolo S, Capece U, Splendore A, Avolio A, Mezza T, Iozzo P, Pontecorvi A, Calcagni ML, Burzotta F, D'Amario D, Crea F, Leccisotti L, Giaccari A. Coronary flow reserve increase after 4-year dapagliflozin treatment in patients with type 2 diabetes: the DAPAHEART follow-up study. Cardiovasc Diabetol. 2025 Aug 31;24(1):351. doi: 10.1186/s12933-025-02912-4.
- Derived from this study: PubMed 38115004Cinti F, Leccisotti L, Sorice GP, Capece U, D'Amario D, Lorusso M, Gugliandolo S, Morciano C, Guarneri A, Guzzardi MA, Mezza T, Capotosti A, Indovina L, Ferraro PM, Iozzo P, Crea F, Giordano A, Giaccari A. Dapagliflozin treatment is associated with a reduction of epicardial adipose tissue thickness and epicardial glucose uptake in human type 2 diabetes. Cardiovasc Diabetol. 2023 Dec 19;22(1):349. doi: 10.1186/s12933-023-02091-0.
- Derived from this study: PubMed 37883003Capece U, Pavanello C, Cinti F, Leccisotti L, Mezza T, Ciccarelli G, Moffa S, Di Giuseppe G, Soldovieri L, Brunetti M, Giordano A, Giaccari A, Calabresi L, Ossoli A. Dapagliflozin-Induced Myocardial Flow Reserve Improvement is not Associated with HDL Ability to Stimulate Endothelial Nitric Oxide Production. Diabetes Ther. 2024 Jan;15(1):257-268. doi: 10.1007/s13300-023-01491-5. Epub 2023 Oct 26.
- Derived from this study: PubMed 36057768Leccisotti L, Cinti F, Sorice GP, D'Amario D, Lorusso M, Guzzardi MA, Mezza T, Gugliandolo S, Cocchi C, Capece U, Indovina L, Ferraro PM, Iozzo P, Crea F, Giordano A, Giaccari A. Dapagliflozin improves myocardial flow reserve in patients with type 2 diabetes: the DAPAHEART Trial: a preliminary report. Cardiovasc Diabetol. 2022 Sep 3;21(1):173. doi: 10.1186/s12933-022-01607-4.
- Derived from this study: PubMed 34037951Sorice GP, Cinti F, Leccisotti L, D'Amario D, Lorusso M, Guzzardi MA, Mezza T, Cocchi C, Capece U, Ferraro PM, Crea F, Giordano A, Iozzo P, Giaccari A. Effect of Dapagliflozin on Myocardial Insulin Sensitivity and Perfusion: Rationale and Design of The DAPAHEART Trial. Diabetes Ther. 2021 Jul;12(7):2101-2113. doi: 10.1007/s13300-021-01083-1. Epub 2021 May 26.
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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.
Andrea Giaccari principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Dapagliflozin 10Mg Tab in people with Type2 Diabetes Mellitus and Stable Coronary Artery Disease, run by Giaccari Andrea at 1 site in Italy.
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 11 inclusion and 23 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 8 May 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 Italy. 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 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?
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?
Effect of dapagliflozin on myocardial insulin sensitivity (time frame: 4 weeks). 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 NCT03313752, which also lists 5 linked publications.
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 8 May 2026.