Diabetes MellitusPhase 4ADOPTNCT04286399
Asian Diabetes Outcomes Prevention Trial
A Phase 4 study testing Renin-angiotensin-aldosterone system inhibitors, Beta blocker and SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product in people with Diabetes Mellitus and Cardiovascular Diseases, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- Renin-angiotensin-aldosterone system inhibitors, Beta blocker and SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2019to 30 Jun 2034
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes for at least six months
- ≥ 40 years of age, men or women
- No known cardiovascular disease ( defined as known coronary stenosis > 70%, reduced left ventricular ejection fraction < 40%, or a history of myocardial infarction/ coronary revascularization/ heart failure hospitalization/ stroke/ prior non-traumatic lower limb amputation or angioplasty)
- NT-proBNP > 125 pg/mL
- Written informed consent
Who cannot join
- History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance
- Patients already on a maximum dose of RAASi or beta-blocker
- History of DM ketoacidosis/Type 1 DM
- eGFR < 45ml/min/1.73m2
- Symptomatic hypotension and/or Visit 1 systolic blood pressure (SBP) < 100mmHg.
- Symptomatic bradycardia, high-grade AV blocks (Grade 2 and 3) and/or Visit 1 heart rate (HR) < 60bpm.
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- Any disease other than diabetes lowering the patient's life expectancy to less than two years.
- Chronic infections (E.g. chronic cystitis, recurrent urinary tract infections) or malignancies or uncontrolled thyroid disorder or liver disease
- Systemic treatment with corticosteroids.
- Pregnant or nursing women
- Any other clinical condition that might affect patients' safety during trial, at the investigator's discretion.
- Participation in an investigational drug trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital (SGH)
Singapore, 169608
Serene Ng, Ms, (+65) 6704 2232, serene.ng.b.l@singhealth.com.sg
About this study
The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.
Read the detailed description
Rationale:
Cardiovascular events are the leading cause of death among patients with diabetes. Early identification of high-risk diabetic (DM) patients for intensification of preventive therapy may prevent cardiovascular events.
Aims:
Among biomarker (N-terminal pro-B-type natriuretic peptide, NT-proBNP)-identified high-risk type 2 DM patients without pre-existing cardiovascular disease, to test if intensive preventive therapy (high dose renin-angiotensin-aldosterone system inhibitors [RAASi], beta-blockade, sodium-glucose co-transporter 2 inhibitors [SGLT2i]) may be associated with reduced cardiovascular events compared to standard of care.
Design:
Prospective multinational randomized open-label, parallel group, active-controlled, two-arm, long-term morbidity and mortality trial involving 5 Asian regions (Singapore, Malaysia, China, Taiwan, India; estimated 6 sites each) with patients followed for 2 years.
Population:
Adults with type 2 DM without known cardiovascular disease (defined as known coronary stenosis > 70%, reduced left ventricular ejection fraction < 40%, or a history of myocardial infarction/coronary revascularization/heart failure hospitalization/stroke/prior non-traumatic lower limb amputation or angioplasty) and with NT-proBNP > 125 pg/mL
Duration:
The goal is to include approximately 2,400 patients. It is estimated that about 3,000 patients with NT-proBNP > 125pg/mL have to be screened. The screen failure rate, for reasons other than NT-proBNP, is anticipated to be approximately 20%. The observation period is planned to last for two years. However, the trial is event driven and will continue until predefined event rate is reached (see sample size calculation). The total trial duration is expected to last for four years (two years of recruitment and a two-year observation period after last patient in). Every patient will remain in the study for two years after randomization.
Visits:
Visit 1:
Pre- Screening
Patients who fulfil the first three pre-screening criteria will proceed for NT-proBNP Point-of-Care (POC) testing:
- Type 2 diabetes for at least 6 months (ADA definition)
- Informed consent
- Check Inclusion/exclusion criteria
- NT-proBNP (assessed through local point of care device) *If the results for NT-proBNP fall > 125pg/mL, the patients will proceed for Full-Screening.
Full- Screening
- Patient enrolment details
- Demographic data
- Patient diary (blood pressure, heart rate, blood glucose) - distribution (optional)
- Vital signs -pulse rate and blood pressure
- Height, weight, waist and hip circumference
- Medical history (DM, cardiovascular, general and behavioural)
- Routine Blood sampling for local laboratory, collected from medical record, if available
- Blood collection for Biomarker analysis (Refer to Section 5.3 and Biospecimen manual)
- Urine sample for Urine Albumin/creatinine ratio, collected from medical record, if available
- Electronic randomization (Section 2.6)
- 12-Lead Electrocardiogram (ECG), collected from medical record, if available (For Singapore sites, ECG values are to be acquired, if not available from medical record)
- EuroQoL questionnaire (EQ-5D-5L)
- Drug prescription assessment
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Baseline Adverse Events assessment
- Echocardiography measurements, collected from medical records, if available (all sites)
- Echocardiography image acquisition (for Singapore and Taiwan sites only - optional)
Interim visits for the treatment group Visit 1-4 is mandatory for all patients, interim visits (between Visits 1-2) only for the intensive treatment group for up-titration of RAASi and beta-blockers and initiation/continuation of SGLT2i. The frequency is up to the treating physician and titration steps. A visit is not mandatory for each titration step.
- Patient diary - collect for assessment and distribute new (optional)
- Vital signs -pulse rate and blood pressure
- Routine blood sampling for local laboratory, collected from medical record, if available
- Drug prescription assessment for further up-titration
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Adverse Events assessment Note: SBP and heart rate should not permanently decrease below 100mmHg and 60bpm respectively.
Visit 2 (3 months ± 1 week)
- Patient diary - collect for assessment and distribute new (optional)
- Vital signs -pulse rate and blood pressure
- Routine Blood sampling for local laboratory, collected from medical record, if available
- Urine sample for Urine Albumin/creatinine ratio, collected from medical record, if available
- 12-Lead Electrocardiogram (ECG), collected from medical record, if available (For Singapore sites, ECG values are to be acquired, if not available from medical record)
- Drug prescription assessment1
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Adverse Events assessment
Visit 3 (12 months ± 2 weeks)
- Patient diary - collect for assessment and distribute new (optional)
- NT-proBNP (assessed through local point of care device)
- Vital signs -pulse rate and blood pressure
- Height, weight, waist and hip circumference
- Routine Blood sampling for local laboratory, collected from medical record, if available
- Blood collection for Biomarker analysis (Refer to Section 5.3 and Biospecimen manual)
- Urine sample for Urine Albumin/creatinine ratio, collected from medical record, if available
- 12-Lead Electrocardiogram (ECG), collected from medical record, if available (For Singapore sites, ECG values are to be acquired, if not available from medical record)
- EuroQoL questionnaire (EQ-5D-5L)
- Drug prescription assessment1
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Adverse Events assessment
- Echocardiography image acquisition (for Taiwan only - optional)
Visit 4: End of Study (24 months ± 2 weeks)
- Patient diary - collect for assessment and distribute new (optional)
- Vital signs -pulse rate and blood pressure
- Height, weight, waist and hip circumference
- Routine Blood sampling for local laboratory, collected from medical record, if available
- Urine sample for Urine Albumin/creatinine ratio, collected from medical record, if available
- 12-Lead Electrocardiogram (ECG), collected from medical record, if available (For Singapore sites, ECG values are to be acquired, if not available from medical record)
- EuroQoL questionnaire (EQ-5D-5L)
- Drug prescription assessment
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Adverse Events assessment
Long-term follow-up (LTFU) (36 and 48 months ± 3 weeks)
- Follow up through telephone contact or population registry (if access allowed) until completion of the study
- Long-term cardiovascular events, mortality and hospitalizations.
- Adverse Events assessment
- For all patients, irrespective of whether they reach these two LTFU time points, a final follow-up should be performed at the end of study
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Being tested
- Renin-angiotensin-aldosterone system inhibitors, Beta blocker, SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renin-angiotensin-aldosterone system inhibitorsDrug
Also called Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin II receptor blockers (ARBs)
Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
Beta blockerDrug
Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor ProductDrug
Also called SGLT2 inhibitors
Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Treatment Group | Other | High dose of RAASi and beta-blockers (unless contraindicated) as well as preferential use of SGLT2i as per local drug label guidelines on top of standard therapy. Receives: Drug: Renin-angiotensin-aldosterone system inhibitors; Drug: Beta blocker; Drug: SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product |
| Control Group | No intervention | Standard therapy where the use of SGLT2i at randomization is not encouraged but RAASi and beta-blockers (except for maximal dosage) are allowed. Prescription or up-titration of the study drugs listed under Intensive Treatment is not encouraged. If investigators/treating physicians feel that further prescription or up-titration is required, a thorough justification is mandatory. Unless there is clinically irrefutable reason, every attempt should be made to use other blood pressure lowering drugs than RAASi or beta-blockers, as well as glucose lowering drugs than SGLT2i, in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint based on the first occurrence of cardiovascular death or major adverse cardiovascular event
Stroke/myocardial infarction/heart failures events
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Jul 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, Mackay Memorial Hospital, National Taiwan University Hospital, Peking University People's Hospital, Medanta, The Medicity, India, Public Health Foundation of India, Putrajaya Hospital, Malaysia, Universiti Teknologi Mara
- Responsible party
- Sponsor
- Investigators
- Carolyn Lam Prof, Study director, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286399
- Sponsor's protocol ID
- ADOPT169609
- Acronym
- ADOPT
- Status last verified
- Mar 2021
- First submitted
- 16 Oct 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Diabetes Outcomes Prevention Trial
- ClinicalTrials.gov ID
- NCT04286399
- Acronym / sponsor ID
- ADOPT / ADOPT169609
- Conditions
- Diabetes Mellitus, Cardiovascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Singapore General Hospital, Mackay Memorial Hospital, National Taiwan University Hospital, Peking University People's Hospital, Medanta, The Medicity, India, Public Health Foundation of India, Putrajaya Hospital, Malaysia, Universiti Teknologi Mara
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2034 (estimated)
- First posted
- 27 Feb 2020 (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 this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (>125pg/mL), and (2) intensify therapy using renin-angiotensin system (RAS) antagonists, beta-blockers and sodium glucose co-transporter-2 inhibitors (SGLT2i) for primary prevention of cardiovascular events in this high-risk DM population.
Detailed description
Rationale:
Cardiovascular events are the leading cause of death among patients with diabetes. Early identification of high-risk diabetic (DM) patients for intensification of preventive therapy may prevent cardiovascular events.
Aims:
Among biomarker (N-terminal pro-B-type natriuretic peptide, NT-proBNP)-identified high-risk type 2 DM patients without pre-existing cardiovascular disease, to test if intensive preventive therapy (high dose renin-angiotensin-aldosterone system inhibitors [RAASi], beta-blockade, sodium-glucose co-transporter 2 inhibitors [SGLT2i]) may be associated with reduced cardiovascular events compared to standard of care.
Design:
Prospective multinational randomized open-label, parallel group, active-controlled, two-arm, long-term morbidity and mortality trial involving 5 Asian regions (Singapore, Malaysia, China, Taiwan, India; estimated 6 sites each) with patients followed for 2 years.
Population:
Adults with type 2 DM without known cardiovascular disease (defined as known coronary stenosis > 70%, reduced left ventricular ejection fraction < 40%, or a history of myocardial infarction/coronary revascularization/heart failure hospitalization/stroke/prior non-traumatic lower limb amputation or angioplasty) and with NT-proBNP > 125 pg/mL
Duration:
The goal is to include approximately 2,400 patients. It is estimated that about 3,000 patients with NT-proBNP > 125pg/mL have to be screened. The screen failure rate, for reasons other than NT-proBNP, is anticipated to be approximately 20%. The observation period is planned to last for two years. However, the trial is event driven and will continue until predefined event rate is reached (see sample size calculation). The total trial duration is expected to last for four years (two years of recruitment and a two-year observation period after last patient in). Every patient will remain in the study for two years after randomization.
Visits:
Visit 1:
Pre- Screening
Patients who fulfil the first three pre-screening criteria will proceed for NT-proBNP Point-of-Care (POC) testing:
- Type 2 diabetes for at least 6 months (ADA definition)
- Informed consent
- Check Inclusion/exclusion criteria
- NT-proBNP (assessed through local point of care device) *If the results for NT-proBNP fall > 125pg/mL, the patients will proceed for Full-Screening.
Full- Screening
- Patient enrolment details
- Demographic data
- Patient diary (blood pressure, heart rate, blood glucose) - distribution (optional)
- Vital signs -pulse rate and blood pressure
- Height, weight, waist and hip circumference
- Medical history (DM, cardiovascular, general and behavioural)
- Routine Blood sampling for local laboratory, collected from medical record, if available
- Blood collection for Biomarker analysis (Refer to Section 5.3 and Biospecimen manual)
- Urine sample for Urine Albumin/creatinine ratio, collected from medical record, if available
- Electronic randomization (Section 2.6)
- 12-Lead Electrocardiogram (ECG), collected from medical record, if available (For Singapore sites, ECG values are to be acquired, if not available from medical record)
- EuroQoL questionnaire (EQ-5D-5L)
- Drug prescription assessment
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Baseline Adverse Events assessment
- Echocardiography measurements, collected from medical records, if available (all sites)
- Echocardiography image acquisition (for Singapore and Taiwan sites only - optional)
Interim visits for the treatment group Visit 1-4 is mandatory for all patients, interim visits (between Visits 1-2) only for the intensive treatment group for up-titration of RAASi and beta-blockers and initiation/continuation of SGLT2i. The frequency is up to the treating physician and titration steps. A visit is not mandatory for each titration step.
- Patient diary - collect for assessment and distribute new (optional)
- Vital signs -pulse rate and blood pressure
- Routine blood sampling for local laboratory, collected from medical record, if available
- Drug prescription assessment for further up-titration
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Adverse Events assessment Note: SBP and heart rate should not permanently decrease below 100mmHg and 60bpm respectively.
Visit 2 (3 months ± 1 week)
- Patient diary - collect for assessment and distribute new (optional)
- Vital signs -pulse rate and blood pressure
- Routine Blood sampling for local laboratory, collected from medical record, if available
- Urine sample for Urine Albumin/creatinine ratio, collected from medical record, if available
- 12-Lead Electrocardiogram (ECG), collected from medical record, if available (For Singapore sites, ECG values are to be acquired, if not available from medical record)
- Drug prescription assessment1
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Adverse Events assessment
Visit 3 (12 months ± 2 weeks)
- Patient diary - collect for assessment and distribute new (optional)
- NT-proBNP (assessed through local point of care device)
- Vital signs -pulse rate and blood pressure
- Height, weight, waist and hip circumference
- Routine Blood sampling for local laboratory, collected from medical record, if available
- Blood collection for Biomarker analysis (Refer to Section 5.3 and Biospecimen manual)
- Urine sample for Urine Albumin/creatinine ratio, collected from medical record, if available
- 12-Lead Electrocardiogram (ECG), collected from medical record, if available (For Singapore sites, ECG values are to be acquired, if not available from medical record)
- EuroQoL questionnaire (EQ-5D-5L)
- Drug prescription assessment1
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Adverse Events assessment
- Echocardiography image acquisition (for Taiwan only - optional)
Visit 4: End of Study (24 months ± 2 weeks)
- Patient diary - collect for assessment and distribute new (optional)
- Vital signs -pulse rate and blood pressure
- Height, weight, waist and hip circumference
- Routine Blood sampling for local laboratory, collected from medical record, if available
- Urine sample for Urine Albumin/creatinine ratio, collected from medical record, if available
- 12-Lead Electrocardiogram (ECG), collected from medical record, if available (For Singapore sites, ECG values are to be acquired, if not available from medical record)
- EuroQoL questionnaire (EQ-5D-5L)
- Drug prescription assessment
- Health service resource utilisation assessment
- Cardiovascular events assessment
- Adverse Events assessment
Long-term follow-up (LTFU) (36 and 48 months ± 3 weeks)
- Follow up through telephone contact or population registry (if access allowed) until completion of the study
- Long-term cardiovascular events, mortality and hospitalizations.
- Adverse Events assessment
- For all patients, irrespective of whether they reach these two LTFU time points, a final follow-up should be performed at the end of study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Treatment Group | Other | Drug: Renin-angiotensin-aldosterone system inhibitors, Drug: Beta blocker, Drug: SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor ProductHigh dose of RAASi and beta-blockers (unless contraindicated) as well as preferential use of SGLT2i as per local drug label guidelines on top of standard therapy. |
| Control Group | No intervention | –Standard therapy where the use of SGLT2i at randomization is not encouraged but RAASi and beta-blockers (except for maximal dosage) are allowed. Prescription or up-titration of the study drugs listed under Intensive Treatment is not encouraged. If investigators/treating physicians feel that further prescription or up-titration is required, a thorough justification is mandatory. Unless there is clinically irrefutable reason, every attempt should be made to use other blood pressure lowering drugs than RAASi or beta-blockers, as well as glucose lowering drugs than SGLT2i, in the control group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes for at least six months
- ≥ 40 years of age, men or women
- No known cardiovascular disease ( defined as known coronary stenosis > 70%, reduced left ventricular ejection fraction < 40%, or a history of myocardial infarction/ coronary revascularization/ heart failure hospitalization/ stroke/ prior non-traumatic lower limb amputation or angioplasty)
- NT-proBNP > 125 pg/mL
- Written informed consent
Key exclusion criteria (12 listed)
- History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance
- Patients already on a maximum dose of RAASi or beta-blocker
- History of DM ketoacidosis/Type 1 DM
- eGFR < 45ml/min/1.73m2
- Symptomatic hypotension and/or Visit 1 systolic blood pressure (SBP) < 100mmHg.
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 |
|---|---|---|
| Renin-angiotensin-aldosterone system inhibitorsAlso: Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin II receptor blockers (ARBs)Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial. | Drug | Intensive Treatment Group |
| Beta blockerResearch participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial. | Drug | Intensive Treatment Group |
| SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor ProductAlso: SGLT2 inhibitorsResearch participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial. | Drug | Intensive Treatment Group |
Primary outcome
Combined endpoint based on the first occurrence of cardiovascular death or major adverse cardiovascular event
Time frame: 48 months
Stroke/myocardial infarction/heart failures events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- 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.
Carolyn Lam Prof study director
National Heart Centre Singapore
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 Renin-angiotensin-aldosterone system inhibitors, Beta blocker and SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product in people with Diabetes Mellitus and Cardiovascular Diseases, run by National Heart Centre Singapore at 1 site in Singapore.
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 12 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: looking for participants now, as of the sponsor's last update on 30 Apr 2021. 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 Singapore. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serene Ng Miss (67042232, serene.ng.b.l@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint based on the first occurrence of cardiovascular death or major adverse cardiovascular event (time frame: 48 months). 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 30 Apr 2021.