Type 2 Diabetes MellitusPhase 4NCT03282136
SGLT2i and Incretin and CRTd.
A Phase 4 study testing Incretin Effect, Cardiac Resynchronization therapy defibrillator device and SGLT-2 inhibitor in people with Type 2 Diabetes Mellitus and Heart Failure, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Heart Failure
- What is being tested?
- Incretin Effect, Cardiac Resynchronization therapy defibrillator device and SGLT-2 inhibitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2017to 1 Sep 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.
Who cannot join
- T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic diseases; neoplastic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incretin Treatment and Combined to SGLT2i Effect in Type 2 Diabetes Mellitus Patients Affected by Heart Failure With Depressed Ejection Fraction, and Treated by Cardiac Resynchronization Therapy With a Defibrillator.
Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by CRT. These patients will randomly be treated by incretin v/s SGLT2i vs combined therapy with incretin+SGLT2i (and added to conventional hypoglicemic drugs). In these patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Combined therapy with incretin and SGLT2i may reduce hospital admissions for HF in T2DM v/s incretin and/or SGLT2i therapy (added to conventional hypoglicemic drugs).
- Conditions
- Type 2 Diabetes Mellitus, Heart Failure
- Being tested
- Incretin Effect, Cardiac Resynchronization therapy defibrillator device, SGLT-2 inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incretin EffectDrug
The patients will receive incretins therapy.
Cardiac Resynchronization therapy defibrillator deviceDevice
The patients will receive a Cardiac Resynchronization therapy defibrillator device
SGLT-2 inhibitorDrug
The patients will receive SGLT2i therapy.
| Study group | Role | What they receive |
|---|---|---|
| incretin arm | Active comparator | T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. Receives: Drug: Incretin Effect; Device: Cardiac Resynchronization therapy defibrillator device |
| conventional hypoglycemic drug arm | Placebo comparator | T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. Receives: Device: Cardiac Resynchronization therapy defibrillator device |
| Incretin added to SGLT2i | Active comparator | T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i added to incretin therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. Receives: Drug: SGLT-2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality, and cardiac cause mortality.
Measured: 12 months
CRT responders
Measured: 12 months
Secondary outcomes (1)
hospital admissions for HF
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
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 Type 2 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celestino Sardu, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282136
- Sponsor's protocol ID
- University of Campania
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sardu C, Paolisso P, Sacra C, Santamaria M, de Lucia C, Ruocco A, Mauro C, Paolisso G, Rizzo MR, Barbieri M, Marfella R. Cardiac resynchronization therapy with a defibrillator (CRTd) in failing heart patients with type 2 diabetes mellitus and treated by glucagon-like peptide 1 receptor agonists (GLP-1 RA) therapy vs. conventional hypoglycemic drugs: arrhythmic burden, hospitalizations for heart failure, and CRTd responders rate. Cardiovasc Diabetol. 2018 Oct 22;17(1):137. doi: 10.1186/s12933-018-0778-9.
PubMed 30348145
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incretin Treatment and Combined to SGLT2i Effect in Type 2 Diabetes Mellitus Patients Affected by Heart Failure With Depressed Ejection Fraction, and Treated by Cardiac Resynchronization Therapy With a Defibrillator.
- ClinicalTrials.gov ID
- NCT03282136
- Acronym / sponsor ID
- University of Campania
- Conditions
- Type 2 Diabetes Mellitus, Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 13 Sep 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.
Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by CRT. These patients will randomly be treated by incretin v/s SGLT2i vs combined therapy with incretin+SGLT2i (and added to conventional hypoglicemic drugs). In these patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Combined therapy with incretin and SGLT2i may reduce hospital admissions for HF in T2DM v/s incretin and/or SGLT2i therapy (added to conventional hypoglicemic drugs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| incretin arm | Active comparator | Drug: Incretin Effect, Device: Cardiac Resynchronization therapy defibrillator deviceT2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. |
| conventional hypoglycemic drug arm | Placebo comparator | Device: Cardiac Resynchronization therapy defibrillator deviceT2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. |
| Incretin added to SGLT2i | Active comparator | Drug: SGLT-2 inhibitorT2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i added to incretin therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.
Key exclusion criteria (1 listed)
- T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic diseases; neoplastic diseases.
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 |
|---|---|---|
| Incretin EffectThe patients will receive incretins therapy. | Drug | incretin arm |
| Cardiac Resynchronization therapy defibrillator deviceThe patients will receive a Cardiac Resynchronization therapy defibrillator device | Device | conventional hypoglycemic drug arm, incretin arm |
| SGLT-2 inhibitorThe patients will receive SGLT2i therapy. | Drug | Incretin added to SGLT2i |
Primary outcome
all cause mortality, and cardiac cause mortality.
Time frame: 12 months
CRT responders
Time frame: 12 months
1 secondary outcome
hospital admissions for HF
Time frame: 12 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 25 Jun 2025.
- Derived from this study: PubMed 30348145Sardu C, Paolisso P, Sacra C, Santamaria M, de Lucia C, Ruocco A, Mauro C, Paolisso G, Rizzo MR, Barbieri M, Marfella R. Cardiac resynchronization therapy with a defibrillator (CRTd) in failing heart patients with type 2 diabetes mellitus and treated by glucagon-like peptide 1 receptor agonists (GLP-1 RA) therapy vs. conventional hypoglycemic drugs: arrhythmic burden, hospitalizations for heart failure, and CRTd responders rate. Cardiovasc Diabetol. 2018 Oct 22;17(1):137. doi: 10.1186/s12933-018-0778-9.
- Individual participant dataSharing planned: Undecided
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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 Incretin Effect, Cardiac Resynchronization therapy defibrillator device and SGLT-2 inhibitor in people with Type 2 Diabetes Mellitus and Heart Failure, run by University of Campania Luigi Vanvitelli 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 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 25 Jun 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 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 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?
all cause mortality, and cardiac cause mortality. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT03282136, 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 25 Jun 2025.